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

Model Number RSAR-26

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/12/2022

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported a 26mm sjm rigid saddle ring was chosen for treatment for mitral valve prolapse with severe mitral valve regurgitation.During the procedure the user performed a triangular resection and annuloplasty.The device was placed and appeared to be satisfactory, however, post cardiopulmonary bypass, a transesophageal echocardiogram was performed revealing persistent and moderate mitral regurgitation.There was no structural damage to the ring.The cause for persistent regurgitation may have been related to something other than the ring itself.Undetected aml prolapse was discovered so it was determined that the issue was also associated to this and could be the reason for residual mitral regurgitation.A major component leading to the patients mitral regurgitation (mr) was posterior mitral leaflet (pml) prolapse.There was an improvement after the valve repair and the mr improved from being severe to moderate but the level of residual mr was unacceptable, therefore the patient was placed back on cardiopulmonary bypass (cpb) and underwent a mitral valve replacement (mvr).The device was explanted and exchanged for a new mitral valve, a non- abbott device.The event did lead to a delay in procedure however the extent of the delay did not cause any consequences to the patient.The patient remained stable throughout the procedure and has been discharged.No additional information has been provided.

Manufacturer Narrative

An event of residual regurgitation and previously undetected aml prolapse which could have contributed to the regurgitation 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 PUERTO RICO, LLC; p.o. box 998; lot 20 b st.; caguas, puerto rico 00725
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, LLC; 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: 13757923
• MDR Text Key: 287140706
• Report Number: 3005334138-2022-00140
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734009423
• UDI-Public: 05414734009423
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K042734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: RSAR-26
• Device Catalogue Number: RSAR-26
• Device Lot Number: 8014773
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG