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

Catalog Number 600112480

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

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); Heart Block (4444)

Event Date 07/08/2023

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 chosen for implant.The graft was successfully placed without difficulty.Post implant, the myocardial pacing leads were left in place per usual.On (b)(6) 2023, atrial fibrillation with bradycardia and atrioventricular block were detected via electrocardiogram (ecg).Amiodarone was administered as treatment.Another ecg was taken on (b)(6) 2023, and it was confirmed that the patient was in sinus rhythm.On (b)(6) 2023, the myocardial pacing leads were removed.A transthoracic echocardiogram (tte) was performed on 17 july, which showed a single pericardial effusion in the right ventricle with 17mm in the right anterior ventricle, 17mm next to the pulmonary infundibulum, and 5-6mm in the right inferior ventricle.Another tte was taken on (b)(6) 2023, and the pericardial effusion was the same size (18mm maximum) and was stable.No intervention was provided to treat the pericardial effusion.It was stated that the pericardial effusion was caused by the removal of the myocardial leads.The patient was discharged the following day on (b)(6) 2023.

Manufacturer Narrative

An event of arrhythmia two days after the masters grafted valve was implanted and pericardial effusion caused by the removal of the myocardial leads 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 arrhythmia was not related to valve malfunction.The root cause of the reported event could not be conclusively determined.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: 17455008
• MDR Text Key: 320374116
• Report Number: 2135147-2023-03399
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009515
• UDI-Public: 05414734009515
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2023
• Device Catalogue Number: 600112480
• Device Lot Number: 8064294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 96 KG