Abbott Trifecta / Trifecta GT bioprosthetic aortic heart valves: cases of structural valve deterioration (SVD) (MDA/2020/019)
Manufactured by Abbott – cases of valvular insufficiency and early revision.
Action
Read Abbott’s Technical Bulletin, dated 13 January 2020, on the Trifecta/Trifecta GT bioprosthetic surgical aortic heart valve (Appendix A in the PDF).
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Note precautions regarding proper valve sizing and handling in accordance with the instructions for use (IFU):
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implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissue
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do not oversize the valve
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do not bend the titanium valve stent. The titanium valve stent is not designed as a flexible stent.
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Identify those patients implanted with a 1st generation Trifecta valve and consider implementing enhanced follow-up.
Due to delays caused by the recent COVID-19 healthcare crisis, we are aware that follow-up and assessments may not take place at normal frequency or in the usual manner. Follow-up recommendations should be risk assessed and completed as soon as possible.
- Report suspected or actual adverse events involving all heart valves through your local incident reporting system and/or your national incident reporting authority as appropriate: England, Scotland, Northern Ireland, Wales. You should also report directly to manufacturers if your local or national systems do not.
Action by
Cardiothoracic surgeons / cardiologists
Deadlines for actions
Actions underway: 03 August 2020
Actions complete: 28 September 2020
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Device details
Abbott Trifecta Valve: Models TF-19A, TF-21A, TF-23A, TF-25A, TF-27A, TF-29A
Abbott Trifecta Valve with Glide Technology (GT): Models TFGT-19A, TFGT-21A, TFGT-23A, TFGT-25A, TFGT-27A, TFGT-29A
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1st generation Trifecta aortic surgical replacement valve, originally manufactured by St. Jude Medical, (now Abbott +), was first CE marked (market approval) in March 2010
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An ‘improved’ Trifecta valve became available from August 2015
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The Trifecta GT valve was CE marked in February 2016
| Model number | Description | GTIN |
|---|---|---|
| TF-19A | TRIFECTA VALVE, 19MM | 05414734052016 |
| TF-21A | TRIFECTA VALVE, 21MM | 05414734052023 |
| TF-23A | TRIFECTA VALVE, 23MM | 05414734052030 |
| TF-25A | TRIFECTA VALVE, 25MM | 05414734052047 |
| TF-27A | TRIFECTA VALVE, 27MM | 05414734052054 |
| TF-29A | TRIFECTA VALVE, 29MM | 05414734052061 |
| TFGT-19A | 19mm Trifecta GT Final Package - WR | 05415067018205 |
| TFGT-21A | 21mm Trifecta GT Final Package - WR | 05415067018212 |
| TFGT-23A | 23mm Trifecta GT Final Package - WR | 05415067018229 |
| TFGT-25A | 25mm Trifecta GT Final Package - WR | 05415067018236 |
| TFGT-27A | 27mm Trifecta GT Final Package - WR | 05415067018243 |
| TFGT-29A | 29mm Trifecta GT Final Package - WR | 05415067018250 |
+Abbott purchased St. Jude Medical in January 2017
Problem / background
Since 2010, the MHRA has received 65 UK adverse incident reports relating to 1st generation Trifecta and ‘improved’ Trifecta valves; 5 relate to the Trifecta GT valve.
Most of these reports (57) relate to revision (explant or valve-in-valve repair) due to some form of structural valve deterioration (SVD). The most common reported problems were leaflet damage and/or valvular insufficiency along with a range of other associated concerns. Time to failure, where known, ranged from perioperative to 8 years, with approximately half occurring between 2 to 3 years post implant. Data from our reports does not appear to show any increased tendency for early degeneration associated with valve size See Appendix B in the PDF for more information on these reports.
The MHRA has been monitoring the frequency and nature of these reports over time and working with the manufacturer to understand the factors and mechanism of these potential complications.
Data accumulated by Abbott through their Trifecta long-term (10 year) follow-up and durability studies conclude acceptable clinical outcomes. However, the manufacturer acknowledges that the design of the 1st generation Trifecta valve may increase the likelihood of early degeneration. Specifically, the SVD seen may be a result of having a valve design with externally mounted leaflets, in combination with a stent that may be deformed during implant. Improvements to the valve leaflets and reinforcement of the stent which were implemented in later designs, are expected to reduce this risk (see Appendix B in the PDF).
Abbott has cited important factors that may influence the risk of SVD in these valves, including implant technique (in their technical bulletin) together with other precautions listed in the associated IFU.
As well as creating abnormal stress and strain to the valve, oversizing the Trifecta/Trifecta GT valve could also result in direct contact between the stent post and the aortic wall, which may result in decreased valve durability due to abrasion or fusion of the posts with the aortic wall.
Recently published independent case report studies and articles (though not RCTs - see Appendix B in the PDF for more information), have also helped to draw attention to this issue. One new significant paper based on data from the Finnish National Database (FinnValve registry), reports a SVD rate disparity between Trifecta and a comparator valve. Abbott confirm that all 13 Trifecta revision events reported in this paper, relate to the 1st generation Trifecta vale.
It is likely that most cases of early valve failure such as those outlined above, will be detected either during routine patient surveillance or hospital admission. However, MHRA is recommending that patients who received the 1st generation Trifecta valves are identified and considered for more frequent (enhanced) follow-up*. This advice is due to the potential increased risk of valve deformation during implant, as well as accumulating signals from published case report studies and articles. The form and extent of this follow-up (above the standard annual) should be determined locally on a case-by-case basis.
2017 was the last year that the 1st generation Trifecta was sold in the U.K. Their manufacturing dates range from 09 December 2014 to 15 June 2015, with a shelf life of 4 years. Hence the last valves would have expired in June 2019
The MHRA encourages cardiothoracic surgeons and cardiologists to continue to report all adverse incident reports, including early events of SVD / NSVD (non-structural valve deterioration), to both the manufacturer and the MHRA.
*Due to delays caused by the recent COVID-19 healthcare crisis, we are aware that follow-up and assessments may not take place at normal frequency or in the usual manner. Follow-up recommendations should be risk assessed and completed as soon as possible.
Manufacturer contacts
Name: Luke Gilbertson – Quality Assurance and Regulatory Compliance Specialist (UK & Ireland)
Tel: 01213060482
Email: [email protected]
Distribution
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- Cardiologists
- Cardiology departments
- Cardiology nurses
- Cardiology, directors of
- Cardiothoracic departments
- Cardiothoracic surgeons
- Cardiothoracic surgery directors
- Coronary care departments
- Coronary care nurses
- Medical directors
General Practice
For onward distribution to all relevant staff including GPs, Practice Managers and Practice Nurses.
Note: We are sending this alert to GPs for information only, in case patients ask them about the contents of this notice.
GPs do not need to take any action.
Independent distribution
Establishments registered with the Care Quality Commission (CQC) (England only)
- Hospitals in the independent sector
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Central Alerting System (CAS) by sending an email to: [email protected] and requesting this facility.
Enquiries
England
Send enquiries about this notice to MHRA, quoting reference number MDA/2020/019 or 2019/003/019/468/002
Technical aspects
Alexander McLaren, MHRA
Tel: 020 3080 6000
Email: [email protected]
Clinical aspects
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Email: [email protected]
To report an adverse incident involving a medical device in England use the Yellow Card reporting page
Northern Ireland
Northern Ireland Adverse Incident Centre (NIAIC), CMO Group, Department of Health (Northern Ireland)
Tel: 028 9052 3868
Email: [email protected]
To report an adverse incident involving a medical device in Northern Ireland use the forms on the website.
Alerts in Northern Ireland are distributed via the NICAS system.
Scotland
Incident Reporting and Investigation Centre (IRIC), Health Facilities Scotland, NHS National Services Scotland
Tel: 0131 275 7575
Email: [email protected]
To report an adverse incident involving a medical device in Scotland, email IRIC to request a webform account.
For more information, or if you can’t access the webform, visit the website: how to report an adverse incident
Wales
Population Healthcare Division, Welsh Government
Tel: 03000 255278 or 03000 255510
Email: [email protected]
To report an adverse incident involving a medical device in Wales, use the Yellow Card reporting page and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).
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