MAUDE Adverse Event Report: AGA MEDICAL CORPORATION SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TF-21A

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

Patient Problems Aortic Regurgitation (1716); Heart Failure (2206); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, the sjm trifecta valve was explanted (originally implanted on (b)(6) 2014) and replaced with an m-size perceval sutureless aortic valve (manufacturer: livanova).A tear was observed on the explanted valve from the rcc and the ncc stent post toward the ncc side.Pannus formed on the inflow side of the valve, also.The patient's state was unstable before the explant.The patient remained stable throughout the re-do procedure, and is in stable condition postoperatively.

Manufacturer Narrative

The valve was reportedly explanted due to a tear and pannus formation.The torn leaflet was previously excised and sent for pathological examination by the hospital.A tear was found in the base of leaflet 3, consistent with explant damage.The outflow of stent post 2 was covered with pannus, and outflow pannus was found at stent post 1, which extended onto the base of leaflet 3.No inflammation or significant calcifications were found.The device history record was reviewed to ensure each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.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, the torn leaflet was excised in the field and therefore the tear site could not be examined and the cause of the reported tear could not be determined; however, the outflow pannus and reported inflow pannus had the potential to induce increased stress on adjacent leaflets and created an unbalanced stress relief distribution between all leaflets during coaptation, which may lead to leaflet tears and reduced durability.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10717877
• MDR Text Key: 214167680
• Report Number: 2135147-2020-00449
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2015
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4250659
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR