MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD TRIFECTA¿ GT VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number TFGT-21A

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Chest Pain (1776); Congestive Heart Failure (1783)

Event Date 02/13/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2018, a 21mm trifecta gt valve was implanted in the patient's aortic position.In (b)(6) 2019 (22 months later), during a follow up, no problems, including aortic regurgitation, were observed on echo.On (b)(6) 2020, the patient presented to the hospital due to sudden chest pain that was presumed to be due to acute congestive heart failure and the patient was admitted to the hospital.On (b)(6) 2020, redo avr was performed and the trifecta gt valve was explanted.Upon explant, a vertical tear from the stent post of the left coronary cusp side leading to the non-coronary cusp was observed.The patient is reported to be stable.

Manufacturer Narrative

The reported leaflet tear was confirmed.Leaflet 2 was torn along its base and leaflet 3 was torn away from its stent post.No inflammation or significant calcifications were noted to be present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.This was inclusive of a review of the manufacturing videos, which contained no evidence of anomalies during functional inspection.X-ray examination of the stent did not show evidence of deformation, which is consistent with proper handling of the valve at the time of implant.The extent of damage to the sewing cuff was potential evidence of difficulty removing the valve during explant.In the absence of any calcification or evidence of 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.Histological evaluation revealed mild loss of collagen at one of the tear sites, which could have contributed to the tear.No changes were found to the tissue at the tear site of leaflet 3 along its stent post to suggest a cause of the tear.

• Brand Name: TRIFECTA¿ GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL CATD; 4 robbins drive; westford MA 01886
• MDR Report Key: 9806059
• MDR Text Key: 183009062
• Report Number: 3008452825-2020-00098
• 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
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2021
• Device Model Number: TFGT-21A
• Device Catalogue Number: TFGT-21A
• Device Lot Number: 6020224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR