MAUDE Adverse Event Report: ABBOTT MEDICAL TAILORY FLEXIBLE ANNULOPLASTY BAND; RING, ANNULOPLASTY

Model Number	TARP-31
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 31mm tailor annuloplasty ring was selected for implant.After implanting the ring, testing revealed that there was still moderate regurgitation, which did not achieve the expected effect.After the ring was removed, it was replaced with a mitral valvuloplasty ring of another brand to complete the surgery.The physician alleges that the patient anatomy was the cause of the issue.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable and has been discharged.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that after implanting the ring testing revealed there was still moderate regurgitation and did not achieve expected effect.Also reported that the physician alleged the patient anatomy was the cause of the issue.The investigation of returned band at abbott found that the sewing cuff was fractured in two pieces.Sutures were noted throughout the ring and the ring holder.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 available, the cause of reported event appears to be related to patient anatomy.The exact cause of reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: TAILORY FLEXIBLE ANNULOPLASTY BAND
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21620086
• Report Number: 2135147-2025-01333
• Device Sequence Number: 20542448
• Product Code: KRH
• UDI-Device Identifier: 05415067044457
• UDI-Public: (01)05415067044457(17)281028
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TARP-31
• Device Catalogue Number: TARP-31
• Device Lot Number: 10057224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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: Other
• Patient Age: 65 YR
• Patient Sex: Male