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

Model Number TARN-33

Device Problem Backflow (1064)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2019

Event Type  Injury  

Event Description

On (b)(6) 2002, a 33mm tailor annuloplasty ring was implanted.On (b)(6) 2019, the device was replaced for mitral regurgitation.The patient was reported to be stable postoperatively.No additional information is available.

Manufacturer Narrative

Explant was reported due to mitral regurgitation.The investigation found that the ring was returned fragmented and that there was fibrous pannus ingrowth present one all of the fragments.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 reported event could not be conclusively determined.

• Brand Name: SJM TAILOR ANNULOPLASTY RING
• 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
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8991691
• MDR Text Key: 157405665
• Report Number: 2648612-2019-00074
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000119
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

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: 05/10/2006
• Device Model Number: TARN-33
• Device Catalogue Number: TARN-33
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/16/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 11/11/2019
• Supplement Dates FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2001
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention