MAUDE Adverse Event Report: ABBOTT MEDICAL SÉGUIN¿; RING, ANNULOPLASTY

Model Number	SARP-30
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2025, a 30mm seguin annuloplasty ring was selected for implant.The grade of mitral regurgitation prior to procedure was severe.The ring was implanted.Post-implant, testing was performed and showed that there was still moderate regurgitation.The ring was removed and replaced with an unknown sized non-abbott artificial mitral valve.The patient was reported to have been discharged in stable condition.
Additional Manufacturer Narrative
It was reported that post-implant testing was performed and it showed that there was still moderate regurgitation so the ring was explanted.The investigation found that few sutures on sewing cuff were noted to be cut consistent with implant/explant procedure.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.The cause of the reported incident 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: SÉGUIN¿
• 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: 21635983
• Report Number: 2135147-2025-01410
• Device Sequence Number: 9276814
• Product Code: KRH
• UDI-Device Identifier: 05415067044815
• UDI-Public: (01)05415067044815(17)280413
• 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: 2025
• Device Explanted Year: 2025
• 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): 04/18/2025

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 Model Number: SARP-30
• Device Catalogue Number: SARP-30
• Device Lot Number: 10301902
• 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: 03/04/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2024
• 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 Age: 55 YR
• Patient Sex: Female