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

Model Number TF-25A

Device Problems Backflow (1064); Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/16/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported a patient underwent an explant procedure of their 25mm sjm trifecta valve six years post implant.During a follow-up visit in the clinic, it was discovered the patient had developed aortic regurgitation (ar).On (b)(6) 2021 a re-do aortic valve replacement (avr) was performed.A non-abbott device was chosen and implanted.Post procedure, after reviewing the explant procedure via video, the surgeon had removed the device holding the valve holder, using care not to touch the trifecta valves leaflet.Images of the explanted device provided.The images reveal a leaflet tear and confirm structural valve deterioration (svd).No additional information has been provided.

Manufacturer Narrative

Explant was reported due to regurgitation.The investigation found that leaflet 1 was torn, and mild degenerative changes were found to the leaflet.The was circumferential fibrous pannus ingrowth on the inflow surface which extended onto the bases of all three leaflets.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.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 degenerative changes at the tear site, which could have contributed to the formation of the tear.In addition, the fibrous pannus ingrowth noted 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: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer (Section G): ST. JUDE MEDICAL, BRASIL LTDA.; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 12661776
• MDR Text Key: 277398593
• Report Number: 3001883144-2021-00131
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052047
• UDI-Public: 05414734052047
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2016
• Device Model Number: TF-25A
• Device Catalogue Number: TF-25A
• Device Lot Number: 4878338
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male