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

Model Number	23VAVGJ-515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Cardiac Arrest (1762); Intracranial Hemorrhage (1891); Low Blood Pressure/ Hypotension (1914); Brain Injury (2219)
Date of Event	11/04/2022
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.
Event or Problem Description
Crd_992 - valved grafts pas pl5012-183- r723704301.It was reported that on (b)(6) 2022, a 23mm master series, vavgj was successfully implanted in a 59-year-old patient who was admitted with symptoms of acute dissection of the ascending aorta, type a.Postoperative course was complicated with intracerebral hemorrhage and hemorrhage into the subarachnoid space, and with brain oedema as a consequence.Intensive therapy: mechanical ventilation, fluid therapy, anti-oedemic therapy, parenteral feeding, transfusions of blood-derived preparations (5 units of rbcc, 6 units of ffp, 10 units of platelet concentrate), without success.Clinical and radiological symptoms of injury of higher brain centers and brain stems.On (b)(6) 2022, before noon, several temporary bradycardia episodes and decrease in arterial blood pressure were observed.At 1:50 p.M.The patient¿s death was declared due to acute cardiac arrest, asystole mechanism.
Additional Manufacturer Narrative
An event of brain injury, intracerebral hematomas, brain edema, several temporary bradycardia episodes, decrease in arterial blood pressure and patient death due to cardiac arrest, asystole mechanism was reported.The patient required urgent procedure due to acute ascending aorta dissection.Information from field indicated that at admission the patient was conscious, periodically complaining about sensation of numbness, loss of sensation in lower limbs which could have been exacerbated by the procedure leading to the complications being reported.Field also indicated that, high blood pressure was treated with medication infusion, followed by low blood pressure requiring fluid therapy.Reportedly, patient received intensive therapy including mechanical ventilation, fluid therapy, anti-oedemic therapy, parenteral feeding, transfusions of blood-derived preparations without success.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.Based on the information received, the root cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.H6 health effect - clinical code: codes 1891 and 2219 removed.

• 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: 15924069
• Report Number: 2135147-2022-02348
• Device Sequence Number: 5258244
• 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): 03/10/2023

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 Model Number: 23VAVGJ-515
• Device Catalogue Number: 23VAVGJ-515
• Device Lot Number: 8373163
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White