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

Model Number TF-19A

Device Problem Material Perforation (2205)

Patient Problem Aortic Regurgitation (1716)

Event Date 07/17/2019

Event Type  Injury  

Event Description

On (b)(6) 2013, a 19mm trifecta valve implanted using everting mattress suture technique.Over the past three years, the pressure gradient gradually increased.On (b)(6) 2019, aortic regurgitation was detected by echocardiography and the device was explanted.Upon explant, two separate pin holes were observed in the middle of the right coronary cusp.No prosthetic valve endocarditis (pve) was confirmed.The device was successfully replaced with a regent valve (sn # unknown).The patient is reported to stable throughout the procedure and postoperatively.

Manufacturer Narrative

The holes seen at explant were confirmed.Leaflet three contained two holes.There was circumferential fibrous pannus ingrowth on the inflow surface which narrowed the inflow diameter.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 at the time of commercialization.The cause of the pannus and tears could not be conclusively determined.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ST. JUDE MEDICAL; rua professor jose vieira de mendonça 1301; engenho nogueira - belo horizonte - mg; belo horizonte 31310 -260; BR 31310-260
• MDR Report Key: 8896537
• MDR Text Key: 154407207
• Report Number: 3001883144-2019-00079
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2014
• Device Model Number: TF-19A
• Device Catalogue Number: TF-19A
• Device Lot Number: 3990567
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 09/18/2019
• 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: 58