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

Catalog Number RSAR-32

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Embolism/Embolus (4438)

Event Date 10/19/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant informationna.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 334903435
• Report Number: 2135147-2024-00570
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05415067044716
• UDI-Public: 05415067044716
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: RSAR-32
• Device Lot Number: 8415048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/08/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 100 KG