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

Model Number RIGID SADDLE RING

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Emotional Changes (1831); Headache (1880); Pain (1994)

Event Date 01/10/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical study patient id: (b)(6).It was reported that on (b)(6) 2022 a 34mm rigid saddle ring was successfully implanted.Post procedure the patient had paroxysmal atrial fibrillation, which was treated with medication.On (b)(6) 2022, an magnetic resonance imaging (mri) was performed and revealed that the patient was had an old cerebral vascular accident (cva), most likley during/after surgery.There was no treatment provided, but the resulting chronic sequela was daily migraines.The patient is doing ok.Though they still some pain due on site of the operation wound, complaints of atrial fibrillation once every three days, and has emotional impact due to the operation.The patient is under the care of a psychologist.

Manufacturer Narrative

An event of atrial fibrillation was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Please note, arrhythmia is a potential side effect of the procedure per the rigid saddle ring instructions for use.

• 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: 16387117
• MDR Text Key: 309752223
• Report Number: 2135147-2023-00544
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734009461
• UDI-Public: 05414734009461
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/09/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: RIGID SADDLE RING
• Device Catalogue Number: RSAR-34
• Device Lot Number: 8137074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 04/23/2023
• Supplement Dates FDA Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male