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

Model Number 27VAVGJ-515

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

Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 11/04/2022

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 study patient id: (b)(4).It was reported that on (b)(6) 2022, a 27mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.It was noted that at an unknown point after implant the patient experienced ventricular fibrillation that was preceded by ventricular tachycardia.The patient went into cardiac arrest and had to be shocked with 300 joules for defibrillation.The patient was administered magnesium sulfate, potassium chloride, lignocaine, and given a cordaron infusion.It was noted that after a few minutes the patient again experienced ventricular fibrillation.The patient was again defibrillated, but this time with only 200 joules.The patient's cordaron infusion was increased and administration of lignocaine was changed to intravenous.The patient's condition improved after treatment and there was no longer any ventricular fibrillation detected.The event resulted in the patient becoming hospitalized to monitor their rhythm.The patient's ventricular fibrillation resolved without sequelae.The patient was stable and discharged at the time of report.

Manufacturer Narrative

An event of ventricular fibrillation, ventricular tachycardia and cardiac arrest 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.Information from the field indicated that the field believed the event was related to procedure or patient comorbidity.There was no allegation of malfunction against the abbott device.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

Clinical study patient id:(b)(6).Subsequent to the previously filed report, additional information was received that it is thought that the event is related to procedure or patient comorbidity, no allegation of malfunction against abbott device.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay in 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: 15897729
• MDR Text Key: 304682870
• Report Number: 2135147-2022-02303
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009515
• UDI-Public: 05414734009515
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: 27VAVGJ-515
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 8479484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Race: White