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

Catalog Number 29VAVGJ-515

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

Patient Problem Atrial Fibrillation (1729)

Event Date 11/30/2023

Event Type  Injury  

Event Description

Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that (b)(6) 2023, a 29mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.The patient remained hemodynamically stable throughout the procedure.There were no difficulties with implanting the device.On (b)(6) 2023, it was confirmed via holter monitor, that the patient developed a new onset of atrial fibrillation.The patient was administered amiodarone, converted to sinus rhythm, and had no reoccurrence of atrial fibrillation.There was no prolonged hospitalization due to the atrial fibrillation.On (b)(6) 2023, the patient was discharged home.

Manufacturer Narrative

An event of atrial fibrillation was reported.Information from field indicated that the graft was successfully implanted, and there were no adverse patient effects or device deficiencies noted during procedure.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Patient had history of hypertension which may contributed to the reported event.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 the reported incident could not be conclusively determined.

• 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: 18400086
• MDR Text Key: 331476078
• Report Number: 2135147-2023-05708
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 29VAVGJ-515
• Device Lot Number: 8573632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2022
• 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): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 108 KG