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

Model Number	SARP-36
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning for evaluation.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) 2025, a 36mm seguin annuloplasty ring was chosen for a mitral valve repair surgery.After the successful implantation of the annuloplasty ring, the physician found that there was still obvious regurgitation of the mitral valve during testing.Therefore, they decided to remove the seguin annuloplasty ring and replace it with an non-abbott ring of the same model for reimplantation.The surgery was successfully completed with no regurgitation observed and the patient was in stable condition.
Event or Problem Description
It was reported that on (b)(6) 2025, a 36mm seguin annuloplasty ring was chosen for a mitral valve repair surgery.After the successful implantation of the annuloplasty ring, the physician found that there was still obvious regurgitation of the mitral valve during testing.Therefore, they decided to remove the seguin annuloplasty ring and replace it with an non-abbott ring of the same model for reimplantation.The surgery was successfully completed with no regurgitation observed and the patient was in stable condition.
Additional Manufacturer Narrative
Explant due to lack of effect (mitral regurgitation) was reported.The investigation found the device met visual specifications.The ring was returned with sutures were observed on the ring.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 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: 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: 23617770
• Report Number: 2135147-2025-06773
• Device Sequence Number: 8969181
• Product Code: KRH
• UDI-Device Identifier: 05415067044877
• UDI-Public: (01)05415067044877(17)280608
• 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): 01/13/2026

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-36
• Device Catalogue Number: SARP-36
• Device Lot Number: 10382286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2024
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 78 KG