MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. TAILOR FLEXIBLE ANNULOPLASTY BAND; RING, ANNULOPLASTY

Model Number TAB-29

Device Problem Backflow (1064)

Patient Problem Tricuspid Regurgitation (2112)

Event Date 06/04/2020

Event Type  malfunction  

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) 2020, a 29mm tailor flexible annuloplasty band was used for tricuspid valvuloplasty.However, tricuspid regurgitation was significant and persistent; it could not be controlled by the tailor band.The tailor band was explanted, and a tricuspid valve replacement was performed.A 29mm epic stented porcine heart valve w/flexfit system was implanted and the surgery was completed.The surgeon attributes the issue to the patient's condition and the procedure.The patient is stable.

Manufacturer Narrative

An event of continued regurgitation following implant was reported.A more comprehensive assessment could not be performed since the device was not returned for analysis.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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TAILOR FLEXIBLE ANNULOPLASTY BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• MDR Report Key: 10228334
• MDR Text Key: 200024199
• Report Number: 2648612-2020-00064
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K022363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TAB-29
• Device Lot Number: 7080570
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention