MAUDE Adverse Event Report: ABBOTT MEDICAL SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number	RIGID SADDLE RING
Medical Device Problem Code	Lack of Effect (4065)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	09/10/2022
Type of Reportable Event	Serious Injury
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) 2022, a 26mm rigid saddle ring was successfully implanted in a patient.The ring had been sized using a ring sizer set.However, post-implant, there was severe mitral regurgitation (mr) confirmed via transesophageal echocardiogram examination.The patient had been taken off bypass to check effectiveness of the ring, but was placed back on bypass after confirming severe mr.The ring was explanted and replaced intraoperatively with a 25mm sjm masters series valve with expanded cuff to complete the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.The patient was stable and recovering at the time of report.The cause for the severe mitral regurgitation is unknown.
Additional Manufacturer Narrative
An event of explant due to severe mitral regurgitation was reported.The device met visual specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications at the time of commercialization.The cause of the reported event could not be conclusively determined.Images from field appeared to show a ring when attached and detached from holder.

• Brand Name: SJM RIGID SADDLE 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: 15533879
• Report Number: 2135147-2022-01455
• Device Sequence Number: 12076267
• Product Code: KRH
• UDI-Device Identifier: 05414734009423
• UDI-Public: 05414734009423
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K042734
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 06/27/2026
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-26
• Device Lot Number: 8034259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 10/03/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown