MAUDE Adverse Event Report: ABBOTT MEDICAL SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING; RING, ANNULOPLASTY

Catalog Number	SARP-30
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	10/21/2023
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 30mm seguin semi-rigid saddle ring was chosen for a mitral valve repair.The ring was implanted, but regurgitation did not subside.The ring was removed by open heart surgery, and a new non-abbott valve was implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported as stable.
Event or Problem Description
It was reported that on (b)(6) 2023, a 30mm seguin semi-rigid saddle ring was chosen for a mitral valve repair.The ring was implanted, but regurgitation did not subside.The patient had been taken off cardiopulmonary bypass (cpb) and was placed back on for further intervention.The ring was explanted, and a new non-abbott valve was implanted.The patient was reported as stable.
Additional Manufacturer Narrative
An event of regurgitation was reported.The device met all visual specifications when analyzed at abbott.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: SJM SéGUIN SEMI-RIGID ANNULOPLASTY RING
• 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: 18121150
• Report Number: 2135147-2023-04990
• Device Sequence Number: 20711050
• Product Code: KRH
• UDI-Device Identifier: 05414734007511
• UDI-Public: 05414734007511
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092310
• 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): 01/05/2024

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: 04/09/2026
• Device Catalogue Number: SARP-30
• Device Lot Number: 8430413
• 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: 10/23/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2022
• 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 Sex: Unknown