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 Problems Atrial Fibrillation (1729); Bradycardia (1751)

Event Date 07/17/2023

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).It was reported that on (b)(6) 2023, a 29mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.On (b)(6) 2023, it was noted via electrocardiogram, that the patient developed an onset of atrial fibrillation after feeling lightheaded.The patient denied any feeling of shortness of breath or chest pain.On (b)(6) 2023, the decision was made to perform a cardioversion.

Manufacturer Narrative

Additional information: g3, g6, h2, h6, h10 an event of arrhythmia three 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 that there was no allegation of malfunction against the device and that the event was related to the implant procedure.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6) subsequent to the previously filed report, additional information was received that there was no difficulty implanting the 29mm sjm masters series valsalva aortic valved graft.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.The patient had a normal sinus rhythm prior to procedure.It was noted that on (b)(6)2023, the patient became hypotensive and light headed before an onset of atrial fibrillation with rapid ventricular response.The decision was made to start/administer the patient on amiodarone with bolus protocol.The patient was sent to the intensive care unit for an emergent direct current cardioversion (dccv), but returned to sinus rhythm prior to performing the dccv.The patient was recovering in sinus bradycardia as of (b)(6) 2023.The patient was discharged at the time of report.

• 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: 17862385
• MDR Text Key: 324821824
• Report Number: 2135147-2023-04291
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• 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: 8891568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2023
• 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): Other; Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Race: White