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

Model Number	TARP-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
(b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2024, a 35mm tailor annuloplasty ring was implanted.Post-procedurally, it was reported on (b)(6) 2024, the patient had a 2mm sternal disjunction that was well tolerated.The patient was indicated for sternal resynthesis in view of persistent sternal pseudo-osteoarthritis.It was reported medical therapy was provided.The patient status was reported stable.
Additional Manufacturer Narrative
It was reported that post-procedure the patient had a 2 mm sternal disjunction that was well tolerated.The patient was indicated for sternal resynthesis in view of persistent sternal pseudo-osteoarthritis.A more comprehensive assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was also 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 incident could not be conclusively determined.The reported unexpected medical intervention was due to medical therapy provided.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: 22159474
• Report Number: 2135147-2025-02974
• Device Sequence Number: 15272281
• Product Code: KRH
• UDI-Device Identifier: 05414734007726
• UDI-Public: (01)05414734007726(17)281209
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 06/20/2025

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 Model Number: TARP-35
• Device Catalogue Number: TARP-35
• Device Lot Number: 10118890
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 84 KG