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

Model Number	25VAVGJ-515
Medical Device Problem Codes	Incomplete Coaptation (2507); Insufficient Device Problem Information (3190); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Aortic Valve Insufficiency/ Regurgitation (4450); Insufficient Information (4580)
Date of Event	05/04/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The implant date, event date and death date are approximated to (b)(6) 2021 as it was stated the event occurred almost 12 months prior.
Event or Problem Description
This event is being conservatively reported due to a patient implanted with an unknown abbott valve who passed away shortly after procedure, the cause of death remains unknown.It was reported that on an unknown date, an unknown abbott heart valve was implanted.In (b)(6) 2022, a phone call was received from the patient's spouse indicating that the patient had passed away shortly after the procedure because the implanted heart valve had failed.It was indicated that this event occurred almost 12 months prior.No additional information has been provided.
Additional Manufacturer Narrative
An event of regurgitation, a leaflet in the open position, cardiac arrest, and patient death 18 days post-implant was reported.A returned device assessment, including histopathological examination of the valve could not be performed as the device 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.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 respect to labeling design or manufacturing of the deviceh6.Health effect - clinical code: code 4580 removed and medical device problem code: code 3190 removed.
Event or Problem Description
Subsequent to the initially filed information, it was reported that a 25mm sjm masters series valsalva aortic valved graft was implanted on (b)(6) 2021.Prior to procedure, the patient was noted to have severe biventricular heart failure with a low ejection fraction of 15-18% and an aortic aneurysm.On (b)(6) 2021, the patient had a cardiac arrest while at home.The patient was diagnosed with cardiogenic shock.In the intensive care unit (icu), an echocardiogram showed one leaflet in the open position along with valve regurgitation, which was thought to be from an embolic event.On (b)(6) 2021, the patient died in the icu.It was also noted that this event occurred in new zealand and not australia.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• Common Device Name: 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: 14392264
• Report Number: 2135147-2022-00268
• Device Sequence Number: 14671099
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 6936922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 05/13/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 53 YR
• Patient Sex: Male