MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT; HEART-VALVE, MECHANICAL

Catalog Number 25VAVGJ-515

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

Patient Problem Atrial Fibrillation (1729)

Event Date 08/08/2023

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)(6), patient site id: (b)(6).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.The patient remained hemodynamically stable throughout the implant procedure.On (b)(6) 2023, it was noted via electrocardiogram that the patient developed an onset of atrial fibrillation.The cause of the atrial fibrillation was believed to be due to the manipulation of the heart and surgery itself, but the exact etiology was unclear.There was no allegation of malfunction against the implanted device.The decision was made to administered the patient intravenous amiodarone.On (b)(6) 2023, the patient was discharged.

Manufacturer Narrative

An event of onset atrial fibrillation was reported.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.Based on the information received, the cause of reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• 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: 17690174
• MDR Text Key: 322725621
• Report Number: 2135147-2023-03868
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P810002
• 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: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8903929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2023
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Race: White