MAUDE Adverse Event Report: ST. JUDE MEDICAL CATD 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); Dyspnea (1816); Heart Failure (2206)

Event Date 12/13/2019

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) 2015, a 21mm trifecta valve was implanted.On (b)(6) 2019, the valve was explanted due to regurgitation.Associated patient symptoms included dyspnea and heart failure.Upon explant, a hole was observed near one of the cusps.An unknown sized unknown device was successfully implanted.No patient consequences were reported.

Manufacturer Narrative

Explant was reported due to regurgitation.The investigation found that leaflets 2 and 3 contained a tear.All three leaflets had been previously dissected with excised tissue missing.All three leaflets were fibrotically thickened.There was fibrous pannus ingrowth on the outflow surface of leaflet 1.No inflammation or significant calcifications were present.The stent ring was distorted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tear could not be conclusively determined; however, 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.

Event Description

On (b)(6) 2015, a 21mm trifecta valve was implanted.On (b)(6) 2019, the valve was explanted due to regurgitation.Associated patient symptoms included dyspnea and heart failure.Upon explant, a hole was observed near one of the cusps.An unknown sized unknown device was successfully implanted.No patient consequences were reported.

• Brand Name: SJM TRIFECTA 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: 9569039
• MDR Text Key: 174303904
• Report Number: 3008452825-2019-00647
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• Combination Product (y/n): N
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2017
• Device Model Number: TF-21A
• Device Catalogue Number: TF-21A
• Device Lot Number: 4980491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention