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 Problem Atrial Fibrillation (1729)

Event Date 12/20/2022

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 information: (b)(4), patient site id: (b)(6).It was reported that on (b)(6) 2022, a 28mm rigid saddle ring was implanted into a patient.On (b)(6) 2022, paroxysmal atrial fibrillation was discovered after the procedure by electrocardiogram and the patient was treated with amiodarone.A temporary pacemaker was used to treat the fibrillation, and the hospital stay was prolonged to monitor the rhythm.The patient is reported to be discharged.No additional information was provided.

Manufacturer Narrative

An event of paroxysmal atrial fibrillation after the procedure was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated it was unrelated to the the implanted device but was related to the implant procedure.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 16178515
• MDR Text Key: 307481032
• Report Number: 2135147-2023-00201
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 05414734009430
• UDI-Public: 05414734009430
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/31/2023

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-28
• Device Lot Number: 8220660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/16/2023
• Supplement Dates Manufacturer Received: 01/30/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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): Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White