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

Model Number	RSAR-32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cognitive Changes (2551)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Crd_985 - arb pmcf, patient site id: (b)(6).It was reported that on (b)(6) 2022, a 32mm rigid saddle ring was implanted.The day after discharge on (b)(6) 2022, the patient was admitted to the hospital after they reported not feeling well, suffering from "defect of memory" and had "forgotten about things." a computed tomography (ct) scan and ultrasound performed on (b)(6) 2022 did not report any bleeding, stroke, or any other findings.No treatment was reported.The patient was hospitalized overnight for observation and discharged on (b)(6) 2022 after feeling better.
Additional Manufacturer Narrative
It was reported that a week after ring was implanted the patient was admitted to the hospital for not feeling well, suffering from "defect of memory" and had "forgotten about things".A computed tomography scan and ultrasound did not report any bleeding, stroke, or any other findings.No treatment was reported.The device remains implanted and will not return to abbott 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 patient effect could not be conclusively determined.It is possible that procedural conditions may have contributed to the reported event, however could not be confirmed.The reported hospitalization was due to patient being hospitalized overnight for observation and was discharged after feeling better.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22345493
• Report Number: 2135147-2025-03446
• Device Sequence Number: 8520064
• Product Code: KRH
• UDI-Device Identifier: 05415067044716
• UDI-Public: (01)05415067044716(17)270517
• 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: 2022
• 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): 07/25/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: RSAR-32
• Device Catalogue Number: RSAR-32
• Device Lot Number: 8480597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 90 KG