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

Model Number 25VAVGJ-515

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

Patient Problems Atrial Fibrillation (1729); Pericardial Effusion (3271)

Event Date 03/16/2023

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: crd_992 - valved grafts pas, patient site id: (b)(6).It was reported that on 2023, a 25mm sjm masters series valsalva aortic valved graft was successfully implanted.No concomitant cardiac procedures were performed during the same surgery.There were no intraprocedural adverse events or device deficiencies reported.On 2023, the patient was discharged from hospital.On 2023, the patient was hospitalized for newly onset intermittent atrial fibrillation.On transthoracic echocardiogram, pericardial exudate was observed.A pericardiocentesis was performed urgently, and 700 ml of old, bloody fluid was drained.The patient was hospitalized from 2023, and then again from 2023.No patient consequences were reported.

Event Description

Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 25mm sjm masters series valsalva aortic valved graft was successfully implanted.No concomitant cardiac procedures were performed during the same surgery.There were no intraprocedural adverse events or device deficiencies reported.On (b)(6) 2023, the patient was discharged from hospital and was on warfarin for anti-thrombotic treatment.On (b)(6) 2023, the patient was hospitalized for newly onset intermittent atrial fibrillation which was believed to be related to the implant procedure.The anti-arrhythmic medication amiodarone was administered.On transthoracic echocardiogram, pericardial exudate was observed.A pericardiocentesis was performed urgently, and 700 ml of old, bloody fluid was drained.The anti-thrombotic regimen was not adjusted after the pericardial effusion was detected and drained.The patient was hospitalized from (b)(6) 2023, and then again from (b)(6) 2023.No patient consequences were reported.

Manufacturer Narrative

An event of atrial fibrillation and pericardial effusion was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated the reported event o was likely due to the implant procedure.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: 16756714
• MDR Text Key: 313488149
• Report Number: 2135147-2023-01687
• 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,Followup
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8261268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2021
• 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; Hospitalization; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Race: White