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

Model Number	TARP-27
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	04/21/2023
Type of Reportable Event	Serious Injury
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 (b)(6) 2023, a 27mm sjm tailor¿ annuloplasty ring was selected for implant to repair the mitral valve.After implantation of the tailor ring, the physician found that there was still a moderate regurgitation.The physician alleged that the material of the tailor ring was too soft to reshape the annular.Because of this, the anterior leaflet and the posterior leaflet couldn¿t align well.The physician explanted the mitral ring and it was replaced with a 27mm masters mechanical heart valve instead.The procedure time was extended about 25 minutes.The procedure was finished successfully without patient consequence.The patient remained stable throughout the procedure and is currently safe and stable.
Additional Manufacturer Narrative
Explant due to moderate regurgitation was reported.It was also reported that anterior leaflet and the posterior leaflet couldn¿t align well as the material of the tailor ring was too soft to reshape the annular.The investigation found that the ring was noted to be blue/purple in color.No damage or anomalies were noted 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 at the time of commercialization.The cause of the 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): 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: 16948681
• Report Number: 2135147-2023-02147
• Device Sequence Number: 6356391
• Product Code: KRH
• UDI-Device Identifier: 05414734007689
• UDI-Public: 05414734007689
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 07/18/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2024
• Device Model Number: TARP-27
• Device Catalogue Number: TARP-27
• Device Lot Number: 7125912
• 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: 04/23/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2019
• 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: 58 YR
• Patient Sex: Female