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

Catalog Number	TARP-29
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on 18 june 2024, a 29mm tailor annuloplasty ring was selected for implant.The dimensions of the native valve are not available.The mitral valve was sized with a tarp sizer set.After the ring was implanted, during saline test, it was determined that there was significant regurgitation; further described as moderate.The 29mm ring was explanted and replaced with a new 30mm rigid saddle ring, which was successfully implanted.There are no allegations of malfunction with the first ring.The patient was hemodynamically stable throughout the procedure.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of lack of effect and mitral regurgitation after implant was reported.The device was returned to abbott for investigation.The investigation found no damage or anomalies to the ring.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 lack of effect and mitral regurgitation could not be conclusively determined.The reported surgical intervention was a result of case-specific circumstances as the device was explanted and a larger ring was implanted.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): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 19727554
• Report Number: 2135147-2024-03367
• Device Sequence Number: 20880559
• Product Code: KRH
• UDI-Device Identifier: 05415067044433
• UDI-Public: (01)05415067044433(17)280829(10)9219965
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K022363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 09/09/2024

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 Catalogue Number: TARP-29
• Device Lot Number: 9219965
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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: Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 59 KG