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

Catalog Number 25VAVGJ-515

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891)

Event Date 05/24/2023

Event Type  Death  

Event Description

It was reported that on (b)(6) 2023, a 25mm master series, vavgj was selected for an implant to replace the aortic root and ascending aorta.During the procedure, partial replacement of aortic root with graft of valved conduit hypothermic (30oc).The peripheral circulation of the patient was arrest and the patient also had antegrade bilateral selective head perfusion.Post procedure day 1, with neurological signs of hemiparesis of the right side.On (b)(6) 2023, a recanalization was performed relating to media infarction.Computer tomography showed media infarct of the left side with shifting to the right because of cardiac thromboembolism.On (b)(6) 2023, emergency craniotomy was performed to decrease the pressure on the left side of the brain.On (b)(6) 2023, echocardiogram revealed thrombi adherent to the 25mm master series,vavgj.The patient's activated clotting time (act) levels was act was < 90 at the time of icu admission, heparin was given.Antixa factor was 0.11 which represents therapeutically anticoagulation.It was also reported that the patient passed away on (b)(6) 2023 due to acute left ventricular failure without any ejection fraction after disabling stoke with craniotomy.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of stroke, hemorrhage, thrombus, embolism and patient death was reported.A returned device assessment could not be performed as the device remained implanted and 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 potential cause of the reported incident could be conclusively determined.However, field noted that patient death was due to acute left ventricular failure without any ejection fraction after disabling stoke with craniotomy.From medical review: the death was caused by the stroke and the need for a craniotomy in combination with the acute left ventricular failure.

• 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: 17789326
• MDR Text Key: 323936785
• Report Number: 2135147-2023-04110
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8998165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2023
• 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): Death