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

Model Number TFGT-21A

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

Patient Problem Aortic Regurgitation (1716)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

After implant, the patient was visiting to the hospital for routine follow up once a year though, ar started to be observed from two years ago.The patient complained subjective symptoms in this year's follow up.Therefore detail examination revealed above moderate degree of ar and mr.The redo was decided.Although the physician who was in charge of explant surgery had not performed for implant procedure, the physician alleged that this findings was attributed to the product itself because early leaflet tear (structural valve deterioration) was observed.On (b)(6) 2020, upon explant valve, a leaflet tear was observed in the commissure between lcc and rcc.The leaflet of rcc side had been torn from the top of the stent post.

Manufacturer Narrative

Explant was reported due to regurgitation and a leaflet tear.The investigation found that leaflet 3 was torn and contained a fold.There was circumferential fibrous pannus ingrowth on the inflow surface which extended onto all the base of all three leaflets.There was also fibrous pannus ingrowth on the outflow surface of leaflets 1 and 2.All three stent posts were twisted and stent posts 1 and 3 were bent.No acute 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 significant 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 potential adverse event 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 and disruption of collagen.Histological evaluation revealed degenerative changes to the collagen at the tear site, which could have contributed to 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.Twisted and bent stent posts were also found.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.Based on the totality of these findings demonstrating host to device interaction (pannus formation), and stent post deformation in combination with biological degeneration of the collagen fibers at the tear sites, the valve may have been subjected to increased operational leaflet stress and biological factors that potentially contributed to the occurrence of the observed leaflet tears.However, it cannot be conclusively determined whether the observed stent deformation occurred before or after valve explant making it difficult to determine conclusively the exact cause of the torn leaflets.

• Brand Name: TRIFECTA GT 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: 11021394
• MDR Text Key: 221844862
• Report Number: 3008452825-2020-00698
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067018212
• UDI-Public: 05415067018212
• 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: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2018
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 5592695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 57