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

Model Number	RSAR-30
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2021, a 30mm sjm rigid saddle ring was implanted.After placing the ring, there was still too much of a leak and it was decided to do a valve replacement.The patient suffered from mitral valve insufficiency and the native valve was affected with rheumatic fever.27mm sjm master series mechanical valve was successfully implanted on (b)(6) 2021.No leakage was noted after the mitral valve replacement was performed.Later, the patient experienced decrease vision in the right eye.No diplopia or hemianopia was reported and cause could not be concluded.The patient remained stable throughout the procedure.The patient was discharged to the referring hospital on (b)(6) 2021.On (b)(6) 2021, the patient was experiencing post operative anemia and was transfused.The patient does not have a history of anemia.The patient is reported to be in stable condition.((b)(4)).Related manufacturer report number: 3007113487-2022-00021.
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Additional Manufacturer Narrative
Additional information: h6, h10.An event of leak remaining after the ring was implanted so it was explanted and a prosthetic valve was implanted was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: SJM RIGID SADDLE RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 177 east county road b; st. paul MN 55117
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13285012
• Report Number: 3007113487-2022-00020
• Device Sequence Number: 12006579
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 07/20/2026
• Device Model Number: RSAR-30
• Device Catalogue Number: RSAR-30
• Device Lot Number: 8062729
• Was Device Available for Evaluation?: No
• 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: 12/22/2021
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 27MJ-501, (B)(6)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 60 KG