MAUDE Adverse Event Report: ST. JUDE MEDICAL PUERTO RICO, INC. SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number	RSAR-26
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Codes	Rupture (2208); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.The results, method, and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2021, that a 26 mm sjm rigid saddle ring was successfully implanted for a mitral valve repair.After the surgery, transesophageal echocardiogram (tee) showed no mitral regurgitation (mr).On (b)(6) 2021, 2d echo showed that there was severe mr.The device was explanted and replaced with a 27 mm sjm masters series valve expanded cuff to resolve the event.No additional information was provided.
Additional Manufacturer Narrative
Additional information: b7, d9, g3, h2, h3, h6, h10.Correction: b5.An event of regurgitation due to chordal rupture and explant of the device 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.The cause of the reported event could not be conclusively determined.
Event or Problem Description
It was reported that on (b)(6) 2021, that a 26 mm sjm rigid saddle ring was successfully implanted for a mitral valve repair in a patient with pre-existing conditions of rheumatic heart disease.After the surgery, transesophageal echocardiogram (tee) showed no mitral regurgitation (mr).On (b)(6) 2021, 2d echo showed that there was severe mr due to chordal rupture.The device was explanted and replaced with a 27 mm sjm masters series valve expanded cuff to resolve the event.The patient remained hemodynamically stable throughout the procedure.No additional information was provided.

• Brand Name: SJM RIGID SADDLE RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC.; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13176435
• Report Number: 2648612-2022-00003
• Device Sequence Number: 4562597
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 05/10/2025
• Device Model Number: RSAR-26
• Device Catalogue Number: RSAR-26
• Device Lot Number: 7510429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2020
• 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
• Patient Sex: Unknown