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

Catalog Number 27VAVGJ-515

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

Patient Problem Ventricular Fibrillation (2130)

Event Date 07/24/2023

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: crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 27mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.It was noted post-implant that the patient began to suffer from ventricular fibrillation after being taken off extracorporeal circulation.The decision was made to defibrillate the patient.

Manufacturer Narrative

An event of ventricular fibrillation after the valve was placed was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There was no allegation of malfunction against the abbott device or procedure, but the ventricular fibrillation was attributed to 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 27mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.It was noted post-implant that the patient began to suffer from ventricular fibrillation after being taken off extracorporeal circulation.The decision was made to defibrillate the patient.Subsequent to the previously filed report, additional information was received that the ventricular fibrillation had occurred during procedure after the 27mm sjm masters series valsalva aortic valved graft entered the patient.There was no difficulty experienced implanting the 27mm sjm masters series valsalva aortic valved graft.The patient remained hemodynamically stable throughout the implant procedure and no clinically significant delay in procedure was reported.It was also noted that the patient had a sinus rhythm prior to procedure.The patient was sent to a rehabilitation center after being defibrillated, but no prolonged hospitalization occurred.There is no allegation of malfunction against the abbott device or procedure, but the ventricular fibrillation is attributed to the implant procedure.

• 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: 17791960
• MDR Text Key: 323968048
• Report Number: 2135147-2023-04123
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 9116727
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 70 KG