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

Catalog Number	SARP-28
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
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 28mm seguin annuloplasty ring was selected for implant.After suturing the seguin ring in, it was found that "the ring could not follow the normal movement of the cardiac cycle." the patient's flap ring could not move after the implant of the seguin ring; the cause is unknown.The seguin ring was subsequently explanted.There were no abnormalities or anomalies observed with the seguin ring.A new 28mm seguin annuloplasty ring was implanted.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of ¿the ring could not follow the normal movement of the cardiac cycle¿ was reported.Information from the field indicated that after implant, the patient's flap ring could not move after the implant of the seguin ring; the cause is unknown.The device was returned to abbott for investigation and no anomalies were found on the device.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 available information, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue regarding manufacture, design, or labeling.

• 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): 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: 20567591
• Report Number: 2135147-2024-05452
• Device Sequence Number: 12730916
• Product Code: KRH
• UDI-Device Identifier: 05415067044792
• UDI-Public: (01)05415067044792(17)250605(10)8004559
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092310
• 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): 01/02/2025

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 Expiration Date: 06/05/2025
• Device Catalogue Number: SARP-28
• Device Lot Number: 8004559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2021
• 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