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 Adult Respiratory Distress Syndrome (1696); Heart Block (4444)

Event Date 06/29/2022

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)(6).It was reported that a 27mm master series, vavgj, was implanted on (b)(6) 2022.On (b)(6) 2022, the patient was intubated and ventilated respiratory sedation gradually flattened.Respiratory murmurs were heard symmetrically; circulation was stable and the patient was in sinus rhythm.At approximately 10am, complete heart block was observed and treated with a pacemaker and external epicardial electrodes.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of heart block one day after the implant procedure was reported.Information form the field indicated that the procedure went well, with no complications being reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported heart block 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: 15196203
• MDR Text Key: 297571360
• Report Number: 2135147-2022-00708
• 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: 10/14/2022

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: 01/31/2023
• Device Model Number: 27VAVGJ-515
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 6593138
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/09/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2018
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Race: White