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

Model Number RSAR-30

Device Problem Backflow (1064)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 12/20/2021

Event Type  Injury  

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 289066638
• Report Number: 3007113487-2022-00020
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K042734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 27MJ-501, (B)(6)
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 60 KG