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

Catalog Number	TAB-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	09/03/2023
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
Clinical information: (b)(4)., patient site id: (b)(6).It was reported that on (b)(6) 2023, a 35mm tailor flexible annuloplasty band was successfully implanted in a patient.It was noted that during procedure there was mild left and right ventricular dysfunction, that was treated with inotropes.There was no difficulty implanting the 35mm tailor flexible annuloplasty band.There was no clinically significant delay in procedure reported.It was also noted that the patient had an aortic valve repair done during the same surgery.On (b)(6) 2023, it was noted that the patient had an episode of atrial fibrillation while in the intensive care unit.Preoperative findings indicate that the patient had degenerative, fibroelastic deficiency of the native mitral valve.The decision was made to administer intravenous cordarone.There was no implant of a permanent pacemaker required.The onset of atrial fibrillation is attributed to the implant procedure.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event of atrial fibrillation was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Field indicated that the patient had degenerative, fibroelastic deficiency of the native mitral valve which could have contributed to reported event.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 root cause of the reported incident could not be conclusively determined.However, field noted that atrial fibrillation was due to the implant procedure.

• 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: 17826640
• Report Number: 2135147-2023-04207
• Device Sequence Number: 2301953
• Product Code: KRH
• UDI-Device Identifier: 05414734055727
• UDI-Public: 05414734055727
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K022363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: TAB-35
• Device Lot Number: 9148594
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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: Hospitalization; Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Race: White