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 Codes	Arrhythmia (1721); Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451); Pulmonary Hypertension (4460)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a 23mm ridged saddle ring was implanted.On (b)(6) 2022, mitral valve insufficiency was observed after a mini mitral valvuloplasty.The patient experienced dyspnea.On (b)(6) 2022, the mitral valve was explanted and a new 31mm epic valve was successfully implanted.No patient consequences were reported.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of valve insufficiency about 4 months after the ring was implanted was reported.A returned device assessment could not be performed as the device remains implanted and 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.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: it was reported that on (b)(6) 2022, after the reintervention, the patient was diagnosed with a pleural effusion.They were administered furosmide.It was reported that on (b)(6) 2022, the patients hemoglobin dropped.No treatment was provided.It was reported that on (b)(6) 2022, the patients electrocardiogram (ekg) showed signs of junctional rhythm.The patient was treated with an external pacemaker.It was reported that on (b)(6) 2022, the patient had biventricular heart failure and pulmonary hypertension.On (b)(6) 2023 the patient had a permanent pacemaker implanted.

• 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: 16125562
• Report Number: 2135147-2023-00121
• Device Sequence Number: 17778914
• Product Code: KRH
• UDI-Device Identifier: 05414734009454
• UDI-Public: 05414734009454
• 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: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2023

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: 09/26/2026
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-32
• Device Lot Number: 8153637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2022
• Supplement Date Received by Manufacturer: 03/19/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 60 KG