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	09/14/2022
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 30mm rigid saddle ring was selected for an implant in a patient with mitral valve insufficiency with stenosis due to endocarditis.During the procedure, after the device was implanted, a water injection pressure test showed mild to moderate regurgitation.After adjusting the ring, the result was still not satisfactory.Device was explanted and a new 30mm rigid saddle ring was successfully implanted.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure due to this event.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of regurgitation remaining after implant of the rigid saddle ring was reported.The investigation found the device met visual specifications.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, however uncorrected regurgitation is a potential possible outcome per the instructions for use.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 15546540
• Report Number: 2135147-2022-01497
• Device Sequence Number: 20242800
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/21/2022

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: 01/30/2023
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-30
• Device Lot Number: 6301737
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 12/17/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2018
• 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