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

Catalog Number	23VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Renal Failure (2041); Brain Injury (2219); Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462); Unspecified Tissue Injury (4559)
Date of Event	05/18/2022
Type of Reportable Event	Death
Event or Problem Description
Clinical information: (b)(6) - valved grafts pas.Patient site id: (b)(6).It was reported that on (b)(6) 2022, 23mm sjm masters series valsalva aortic valved graft was successfully implanted.There were no intraprocedural device deficiencies or adverse events reported.On (b)(6) 2022, the patient was diagnosed with an acute kidney injury and had anuria, which was caused by post-operative acute renal failure (unspecified).The patient had multiple cycles of continuous renal replacement therapy and had a history of kidney disease.Patient was unresponsive to the medication furosemide with theophylline.On (b)(6) 2022, the patient had numerous petechiae on the skin of the right foot, and marbled skin on the left thigh, which was believed to be related to the procedure.Patient had necrosis of both feet after intravascular coagulation.On (b)(6) 2022, the patient had symptoms of a brainstem injury and was unable to make active movements in 4 limbs.The brainstem disorder was believed to be related to the procedure.On (b)(6) 2022, the computed tomography (ct) scan of head showed cortical and subcortical atrophy of the brain and cerebellum.On (b)(6) 2022, the patient passed away due to acute heart and pulmonary failure.The death was not believed to be related to the procedure or the implanted device.There were no reported deficiencies with the implanted valved graft, and there was no allegation of malfunction against the device.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of acute kidney injury, anuria, numerous petechia, acute heart, pulmonary failure and death was reported.The death was not believed to be related to the procedure or the implanted device.There were no reported deficiencies with the implanted valved graft, and there was no allegation of malfunction against the device.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record could not be reviewed.Based on the information received, the cause of the reported incident could not be conclusively determined.From medical review : the death is most likely procedure related due to the proximity to the implant procedure, but the exact cause for the cascade of events remains unclear.There is no allegation of a malfunction of the mhv.

• 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: 17606777
• Report Number: 2135147-2023-03697
• Device Sequence Number: 15029613
• Product Code: LWQ
• UDI-Device Identifier: 05414734009522
• UDI-Public: 05414734009522
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2023
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 8373183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2022
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White