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

Model Number	TARP-33
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
(clinical study patient id: (b)(6)).It was reported that on (b)(6) 2021, a 33 mm tailor flexible annuloplasty ring was successfully implanted.On (b)(6) 2021, the patient presented with atrioventricular block type 3.A pacemaker was successfully implanted to resolve the event.No additional information was provided.
Additional Manufacturer Narrative
An event of atrioventricular block was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: TAILOR FLEXIBLE ANNULOPLASTY RING
• Common Device Name: 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: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13281822
• Report Number: 2648612-2022-00008
• Device Sequence Number: 5071125
• Product Code: KRH
• UDI-Device Identifier: 05414734007719
• UDI-Public: 05414734007719
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K014161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2026
• Device Model Number: TARP-33
• Device Catalogue Number: TARP-33
• Device Lot Number: 8074130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG