MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	T505U223
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Endocarditis (1834); Unspecified Infection (1930); Respiratory Failure (2484); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449)
Date of Event	02/05/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that two days post implant of this 23mm aortic bioprosthetic valve the patient was hypoxic and required bilevel positive airway pressure (bipap) therapy and ultimate re-intubation.Respiratory cultures were positive for serratia marcescens and klebsiella pneumoniae, and antibiotic treatment was initiated.The patient developed persistent fever with leukocytosis and lactic acidosis.Antibiotic therapy continued for pneumonia which progressed to hemodynamic instability requiring pressor therapy.Due to persistent hypoxemia, ultrasound was performed and was positive for deep vein thrombosis, and the patient was given anticoagulation treatment.Eleven days post implant, transthoracic echocardiogram (tte) showed a well seated valve with trace aortic insufficiency and aortic valve endocarditis.Eighteen days post implant the 23mm valve, a re-do aortic valve replacement (avr) was performed.Prior to the surgery the surgeon citied an 80% chance of mortality due to the patient's overall ill condition.The 23mm valve was examined intraoperatively, thrombi and vegetations were present on the non-coronary leaflet and paravalvular leak (pvl) was present at the right and left commissure.The 23mm aortic bioprosthetic valve was explanted and replaced with a 23mm aortic root bioprosthesis with no pledgets due to the infection.It was reported that separating from cardiopulmonary bypass (cpb) was very difficult and due to underlying sepsis, malnourishment, and multiple cytokine storm the patient was not a candidate for any ventricular assist device or extracorporeal membrane oxygenation (ecmo).The patient was transferred to the cardiac surgical unit in critical condition with a systolic blood pressure of 50mmhg, no further attempts at resuscitation were deemed appropriate and the patient expired due to cardiogenic shock.No autopsy was performed.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 11570710
• Report Number: 2025587-2021-00951
• Device Sequence Number: 3599159
• Product Code: LWR
• UDI-Device Identifier: 00643169000438
• UDI-Public: 00643169000438
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 08/10/2023
• Device Model Number: T505U223
• Device Catalogue Number: T505U223
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 93