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

Model Number	SARP-28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(4), patient site id: (b)(6).It was reported that on (b)(6) 2022, a 28mm seguin semi-rigid saddle ring was chosen for implant in the mitral valve.This procedure was performed due to history of mitral valve prolapse.A ring sizer set was used during procedure.The mitral valve repair included a cleft closure.The posterior leaflet was repaired.The mitral valve repair included subvalvular repairs, including chordal replacement with artificial chordae or suture.There were no intraprocedural adverse events reported.The ring was successfully implanted.On (b)(6) 2022, the patient was admitted to the hospital for a repeated mitral valve prolapse.On (b)(6) 2022, transthoracic echocardiogram (tte) was performed which was abnormal.On (b)(6) 2022, the device was explanted, and the valve was repaired.A 30mm seguin semi-rigid saddle ring was successfully implanted to resolve this event.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: (b)(6) - arb pmcf, patient site id: (b)(6).Subsequent to the previously filed report, additional information was received that the physician believes this event was caused by the patient's medical history of mitral prolapse.No additional information was provided.
Additional Manufacturer Narrative
An event of mitral valve prolapse one month after device implant so the ring was explanted was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.It was indicated that a larger device was used to replace the originally implanted ring.Information form the field indicated the physician thought the event was due to the patient's history of mitral valve prolapse.There is no indication of a product quality issue with regards to 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): 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: 15321546
• Report Number: 2135147-2022-00950
• Device Sequence Number: 17519132
• Product Code: KRH
• UDI-Device Identifier: 05414734007504
• UDI-Public: 05414734007504
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K092310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: 07/07/2022
• Device Model Number: SARP-28
• Device Catalogue Number: SARP-28
• Device Lot Number: 6534666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Race: White