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

Model Number TF-19A

Device Problems Backflow (1064); Incomplete Coaptation (2507); Biocompatibility (2886); Material Split, Cut or Torn (4008)

Patient Problems Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2017 a 19 mm sjm trifecta valve was implanted.On (b)(6) 2021, during a follow-up visit with the clinic, the patient presented with congestive heart failure symptoms such as shortness of breath and elevated brain natriuretic peptide (bnp).Further evaluation lead to the diagnosis of severe aortic regurgitation.The patient was transferred to a higher level of care for an emergency aortic valve replacement (avr).The 19 mm trifecta valve was explanted and replaced with a competitor valve.Upon explant, the trifecta valve presented with pannus formation and a tear at the stent post between the lcc and the ncc.The lcc also appeared to be prolapsed.There was pannus on both the inflow and the outflow side of the leaflets originally, but it was reported that the pannus on the inflow side peeled off during the explant procedure.An analysis of the early svd is requested and appreciated.The surgeon thinks the issue is due to the tear and prolapse on the valve.

Manufacturer Narrative

Additional information: d9,g3,g6, h2, h3,h6,h10 explant was reported due to heart failure and aortic regurgitation.Also reported was that there was pannus on the inflow of the valve which peeled off during the explant procedure.The tear and pannus seen at explant was confirmed.Leaflets 1 and 2 were torn.Stent post 3 was covered in pannus.Leaflet 1 was folded.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.This was inclusive of a review of the manufacturing videos, which contained no evidence of anomalies during functional inspection.In the absence of any calcification or evidence for 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 demonstrate loss of collagen at one of tear sites, which could have contributed to the formation of the tear.In addition, the reported pannus on the inflow, if it had extended onto the leaflets, had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation, which would lead to leaflet tears and reduced durability.As the pannus on the inflow could not be confirmed, the exact cause of the tear could not be conclusively determined.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; 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: 11698060
• MDR Text Key: 246466220
• Report Number: 3008452825-2021-00214
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• 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
• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2017
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 5271364
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 50