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

Model Number TFGT-23A

Device Problems Backflow (1064); Improper Flow or Infusion (2954); Material Split, Cut or Torn (4008)

Patient Problems Heart Failure (2206); Regurgitation, Valvular (2335)

Event Date 10/19/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017, a 23mm trifecta gt valve was implanted with the non-everting mattress suture technique in the patient's aortic position in which severe calcification on the annulus had occurred.An abbott sizer was used in the surgery.There was no problem observed on the echocardiogram and no cardiac murmur in the follow-up on (b)(6) 2020.However, sudden heart failure occurred in the early (b)(6) 2020 and the patient was hospitalized.Aortic regurgitation due to a leaflet tear was confirmed on the echocardiogram.On (b)(6) 2020, the trifecta gt was explanted and a competitor's valve was successfully implanted.The patient status was reported as unknown.

Manufacturer Narrative

Correction: h6 - device code.Explant was reported due to regurgitation and a leaflet tear.The investigation found that all three leaflets contained calcifications and tears.No inflammation was 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.The cause of the tear could not be conclusively determined; however, the calcifications in the tissue 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: TRIFECTA GT VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA (CVD); parque industrial, zona franca coyol s.a; edificio #44b, calle 0, avenida 2, coyol; alajuela 1897- 4050; CS 1897-4050
• MDR Report Key: 10848398
• MDR Text Key: 216831772
• Report Number: 3008452825-2020-00644
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2018
• Device Model Number: TFGT-23A
• Device Lot Number: 5728352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR