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 07/16/2023

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)(4) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 29mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.It was reported the patient's baseline rhythm was normal sinus rhythm.There was no report of any difficulty implanting the device.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.On (b)(6) 2023, it was noted that the patient developed an onset of atrial fibrillation.It was reported the patient felt nervous but there was no chest pain, shortness of breath, or pre/syncope.The atrial fibrillation is attributed to the implant procedure.The patient was given diltiazem iv 10 mg x 1 and magnesium with significant improvement in duration and frequency of episodes.There was no initial or prolonged hospitalization due to this event.The patient status was reported as recovered and discharged.

Manufacturer Narrative

An event of atrial fibrillation five days after the valve was implanted 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 there was no allegation against the device, and that the event was caused by the implant procedure.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 29mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.It was reported the patient's baseline rhythm was normal sinus rhythm.There was no report of any difficulty implanting the device.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in the procedure.On (b)(6) 2023, it was noted that the patient developed an onset of atrial fibrillation.It was reported the patient felt nervous but there was no chest pain, shortness of breath, or pre/syncope.The atrial fibrillation is attributed to the implant procedure.The patient was given diltiazem iv 10 mg x 1 and magnesium with significant improvement in duration and frequency of episodes.There was no initial or prolonged hospitalization due to this event.The patient status was reported as recovered and discharged.Subsequent to the previously filed report, additional information was received that on (b)(6) 2023, the patient had developed onsets of supraventricular tachycardia, bigeminy, and temporary episodes of second degree atrioventricular block.The decision was made to start the patient on a daily regimen of amiodarone.

Manufacturer Narrative

An event of the patient developing many arrhythmias after the valve was implanted 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 there was no allegation against the device, and that the event was caused by the implant procedure.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17876889
• MDR Text Key: 324991533
• Report Number: 2135147-2023-04330
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• 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: 8939486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2023
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Race: White