MAUDE Adverse Event Report: ABBOTT MEDICAL SJM RIGID SADDLE RING; RING, ANNULOPLASTY

Model Number	RIGID SADDLE RING
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	05/05/2022
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
Clinical information: (b)(4), patient site id: (b)(6).It was reported that on (b)(6) 2021, a 30mm rigid ring saddle was successfully implanted in a patient.On (b)(6) 2022, the patient returned to the hospital due to symptoms of dyspnea.An echocardiogram was performed and discovered ring dehiscence and primary mitral valve regurgitation.There was no signs of progression of the dehiscence.The patient was monitored and given a regimen of heart failure medication.The follow up determine that the patient currently does not require surgical intervention.
Event or Problem Description
Clinical information: (b)(4) , patient site id: (b)(6).It was reported that on (b)(6) 2021, a 30mm rigid saddle ring was successfully implanted in a patient.On (b)(6) 2022, the patient returned to the hospital due to symptoms of dyspnea.An echocardiogram was performed and discovered ring dehiscence and primary mitral valve regurgitation.There was no signs of progression of the dehiscence.The patient was monitored and given a regimen of heart failure medication.The follow up determine that the patient currently does not require surgical intervention.Subsequent to the previously filed report, additional information was received that the patient had also suffered from a right leg edema and worsening heart failure (new york heart association class ii).The patient mitral insufficiency/regurgitation was of grade 1.The patient had initially been prescribed a regimen of entresto 24/26 twice a day and jardiance 10mg a day.After the onset of dyspnea, ring dehiscence, and mitral regurgitation, the patient was prescribed a regimen of bisoprolol (2.5mg per day) and torasemid (10-15mg per day).There is no other intervention other than the added medication.It is unknown what caused the 30mm rigid saddle ring dehiscence and mitral regurgitation.There was no allegation of malfunction against the 30mm rigid saddle ring or procedure.The patient was stable at the time of report.
Additional Manufacturer Narrative
An event of ring dehiscence was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the cause of the dehiscence was unknown.The cause of the reported event could not be conclusively determined.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: 15830865
• Report Number: 2135147-2022-02103
• Device Sequence Number: 5316604
• Product Code: KRH
• UDI-Device Identifier: 05414734009447
• UDI-Public: 05414734009447
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K042734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2023

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: 03/18/2026
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-30
• Device Lot Number: 7894220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/21/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 11/19/2022
• Supplement Report FDA Received Date: 02/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 74 KG