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

Catalog Number	RSAR-32
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Embolism/Embolus (4438)
Date of Event	10/19/2022
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 informationna.
Event or Problem Description
Clinical information: crd_985 - arb pmcf, patient site id: (b)(6).It was reported that on 05 september 2022, a 32mm rigid saddle ring was successfully implanted in a patient.On (b)(6) 2022, it was noted that the patient had developed delirium and visited a clinic.The patient had a head computed tomography scan performed and revealed multiple ischemic cardioembolic apoplex.The decision was made to hospitalize the patient.
Additional Manufacturer Narrative
An event of delirium was reported.Information from the field indicated that the patient had a head computed tomography (ct) scan performed, which revealed multiple ischemic cardioembolic apoplex.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.There was no allegation of malfunction against the abbott device or procedure.Based on the information received, the cause of the reported incident could not be conclusively determined.Removed code: 4438 embolism/embolus.
Event or Problem Description
Clinical information: crd_985 - arb pmcf, patient site id: ((b)(6)) it was reported that on (b)(6) 2022, a 32mm rigid saddle ring was successfully implanted in a patient.There was no difficulty with implantation.On (b)(6) 2022, it was noted that the patient had developed delirium and visited a clinic.The patient had a head computed tomography (ct) scan performed, which revealed multiple ischemic cardioembolic apoplex.The decision was made to hospitalize the patient.The duration of the symptoms lasted a couple of hours.The patient was hospitalized until (b)(6) 2022.No treatment was reported.There was no allegation against the device.On (b)(6) 2022, the patient was discharged and had fully recovered.

• 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: 18668186
• Report Number: 2135147-2024-00570
• Device Sequence Number: 12851508
• Product Code: KRH
• UDI-Device Identifier: 05415067044716
• UDI-Public: 05415067044716
• 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): 03/22/2024

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 Catalogue Number: RSAR-32
• Device Lot Number: 8415048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• 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; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 100 KG