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

Model Number	SARP-28
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 28mm seguin annuloplasty ring was selected for implant.The annular dimension was 40mm.The ring was implanted.However, post-operative echocardiogram showed distorted annulus with moderate/severe regurgitation.The cause of the distorted annulus was reported as "relatively small size annuloplasty ring was used to increase the coaptation.This lead to distortion of annulus." subsequently, the ring was explanted and the valve was repaired with sutures.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
It was reported that following implantation of the ring, echocardiography demonstrated a distorted annulus and moderate to severe regurgitation, attributed to an undersized ring intended to increase leaflet coaptation.A returned-device assessment could not be performed because the original shelf box was received empty, with no device inside.The device history record was reviewed and confirmed that all manufacturing and inspection steps were completed and the product met specifications.Based on the available information, the reported event appears consistent with potential mis-sizing; however, this cannot be conclusively determined.There is no indication of a manufacturing, design, or labeling-related quality issue.
Event or Problem Description
N/a.

• 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: 23018935
• Report Number: 2135147-2025-05116
• Device Sequence Number: 10038408
• Product Code: KRH
• UDI-Device Identifier: 05415067044792
• UDI-Public: (01)05415067044792(17)280113
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K092310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/09/2026

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-28
• Device Catalogue Number: SARP-28
• Device Lot Number: 10158584
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/14/2024
• 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: 29 YR
• Patient Sex: Male
• Patient Weight: 51 KG