MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA (SH) TRIFECTA STENTED TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.Further information was requested but not received.

Event Description

On (b)(6) 2014, a trifecta valve was implanted.On (b)(6) 2020, the valve was explanted and replaced with an inspirus valve.Additional information was requested but not received.

Manufacturer Narrative

The cause of explant of the 6 year old valve was unknown.Morphological and histopathological examination found leaflet 1 had been partially excised.Leaflets 2 and 3 contained tears.Stent post 1 was bent and leaflet 1 contained an tool impression at this post, consistent with explant damage.The outflow of stent post 2 was covered in pannus.No inflammation or significant calcifications were present.In the absence of any calcification or evidence of infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did not demonstrate loss of collagen at the tear site and the cause of the leaflet tear could not be conclusively determined; however, the tissue ingrowth at stent post 2 had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, leading to leaflet tears and reduced durability.

• Brand Name: TRIFECTA STENTED TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (SH); parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 10678236
• MDR Text Key: 211368724
• Report Number: 3008452825-2020-00560
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR