MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; REPLACEMENT HEART-VALVE

Model Number	T505C225
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Embolism/Embolus (4438)
Date of Event	03/12/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that 8 years and 2 months post implant of this 25mm aortic bioprosthetic valve, the patient presented to hospital for hematemesis and hypotension.It was reported that a left lung cavitary lesion for empiric antibiotics was noted and a bronchoalveolar lavage (bal) procedure performed was positive for pseudomonas.A bronchoscopy performed showed bloody lungs and the patients condition progressively worsened.It was stated that a computed tomography scan performed noted large acute stroke affecting the left middle cerebral artery (mca) territory.An electrocardiogram performed noted atrial fibrillation with rapid ventricular response (rvr) and transthoracic echocardiogram (tte) performed showed bioprosthetic valve abnormality, concern for infective endocarditis with embolic shower to brain and spleen.The patient was hospitalized, transfused with 1 unit of blood and medications were given.It was reported that 12 days later, the patient died.The cause of death was reported as cerebrovascular accident due to embolism of the left middle cerebral artery.It was stated that the event was not product or procedure related, it is unknown whether an autopsy was performed.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20675078
• Report Number: 2025587-2024-06503
• Device Sequence Number: 8949718
• Product Code: DYE
• UDI-Device Identifier: 00643169534056
• UDI-Public: 00643169534056
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/04/2018
• Device Model Number: T505C225
• Device Catalogue Number: T505C225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/13/2024
• Date Device Manufactured: 05/05/2015
• 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: Hospitalization; Life Threatening; Death
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White