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

Catalog Number	600074094
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
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 (b)(6) 2024, a 29mm tailor annuloplasty ring was selected for implant to repair a mitral valve.No associated patient symptoms were reported.After implant, mild-moderate mitral regurgitation was still present via follow up imaging, therefore the ring was explanted and the valve was replaced with a non-abbott device.The patient was not closed prior to explanting the ring.The patient status was reported as stable.No patient consequences were reported.There are no allegations of malfunction with the ring and there are no allegations to the sizing of the ring.The patient remained hemodynamically stable throughout the procedure and no clinically significant delay was reported.
Additional Manufacturer Narrative
An event of moderate mitral regurgitation after implantation was reported.The device was returned to abbott in two broken pieces.No other anomalies were noted.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.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: 19929131
• Report Number: 2135147-2024-03843
• Device Sequence Number: 16834233
• Product Code: KRH
• UDI-Device Identifier: 05414734007696
• UDI-Public: (01)05414734007696(17)280726(10)9164122
• 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): 10/17/2024

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: 600074094
• Device Lot Number: 9164122
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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
• Patient Sex: Unknown