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

Model Number TF-25A

Device Problems Backflow (1064); Material Split, Cut or Torn (4008)

Patient Problems Aortic Regurgitation (1716); Cusp Tear (2656)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2016, the patient underwent an operation at (b)(6) hospital and a 25mm sjm trifecta valve was successfully implanted in the patient.During the patient's follow-up, the echo showed regurgitation from one of the cusp areas.On (b)(6) 2020, the patient underwent a re-do operation and the valve was explanted and replaced.During the operation, the valve visually looked good, but there was one cusp detached from the top of the stent post.The patient was stable during the first post-operation date.

Manufacturer Narrative

Explant was reported due to regurgitation and a leaflet tear was noted.The investigation found that there was circumferential fibrous pannus ingrowth on the inflow surface which narrowed the inflow diameter.There was detached fibrous pannus on the outflow surface of leaflet 2.Leaflet 1 was torn.There was a fold/retraction in leaflet 1 which would have contributed to incomplete coaptation.No acute inflammation or significant calcifications were present.Stent post 2 was bent slightly outward.The device history record was reviewed and confirmed that each manufacturing and inspection operation was performed and that the product met all specifications.This was inclusive of a review of the manufacturing videos during functional testing, which contained no evidence of anomalies, including stent deformation, during functional inspection.In the absence of any calcification or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.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.Histological evaluation demonstrated loss of collagen at the tear site, which could have contributed to the tear.There was also evidence of an outwardly bent stent post.An outward bent stent post may result in a localized increase in leaflet stress which may potentially contribute to the observed non-calcific leaflet tear.However, it could not be conclusively determined whether the stent deformation occurred before or after the valve explant.In addition, the pannus noted on the inflow surface of the leaflets likely induced increased stress on adjacent leaflets and created an unbalanced stress relief distribution between all leaflets during coaptation, which could have contributed to the leaflet tear and reduced durability.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); 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: 10500088
• MDR Text Key: 206151547
• Report Number: 3008452825-2020-00445
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• 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,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2017
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 5296053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 09/07/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention