BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 11121414 · Received January 5, 2021

    Report

    Report Number
    2025587-2021-00035
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    September 11, 2012
    Report Date
    January 5, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: WEIMAR T ET AL. STRATEGIES FOR BIOLOGICAL HEART VALVE REPLACEMENT: STENTLESS XENOGRAFTS FAIL TO EVOLVE INTO AN ALTERNATIVE PULMONARY VALVE SUBSTITUTE IN A ROSS PROCEDURE. BIOTECHNOL J. 2013 MAR;8(3):345-51. DOI: 10.1002/BIOT.201200288. ARTICLE ONLINE 11 SEP 2012. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE EARLY AND MID-TERM OUTCOMES OF STENTLESS BIOPROSTHESES IN COMPARISON TO PULMONARY HOMOGRAFTS AS THE PULMONARY VALVE SUBSTITUTE IN THE ROSS PROCEDURE. ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 2004 AND 2008. THE OVERALL STUDY POPULATION INCLUDED 139 PATIENTS AND WAS DIVIDED INTO TWO GROUPS: HOMOGRAFT GROUP (106 PATIENTS) AND STENTLESS GROUP (33 PATIENTS). IN THE STENTLESS GROUP, ALL PATIENTS UNDERWENT RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION WITH MEDTRONIC FREESTYLE BIOPROSTHETIC VALVES (PREDOMINANTLY MALE, MEDIAN AGE 43 YEARS). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL 139 PATIENTS, THE OVERALL MORTALITY AT ONE-YEAR FOLLOW-UP WAS 1.4% (2 PATIENTS). THE CAUSES OF DEATH INCLUDED: CARDIAC ARREST THAT OCCURRED NINE DAYS AFTER DISCHARGE AND MEDICATION-INDUCED BRADYCARDIA WAS SUSPECTED (1), AND NON-CARDIOVASCULAR CAUSES (1). THE TYPE OF PRODUCT (PULMONARY HOMOGRAFT OR STENTLESS FREESTYLE VALVE) IMPLANTED IN THESE TWO PATIENTS WAS NOT REPORTED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL 139 PATIENTS, ADVERSE EVENTS INCLUDED: REOPERATION DUE TO DOUBLE-VALVE ENDOCARDITIS (IMPLANT DURATION UNKNOWN). BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT. AMONG ALL PATIENTS IN THE STENTLESS GROUP, ADVERSE EVENTS INCLUDED: REOPERATION FOR BLEEDING OR PERICARDIAL EFFUSION; VALVE EXPLANTED AND REPLACED WITHIN TWO YEARS POST-IMPLANT DUE TO FIBROUS TISSUE INGROWTH AT THE PROXIMAL ANASTOMOSIS CAUSING ELEVATED GRADIENTS (MORE THAN 30 MMHG); AND MILD TO SEVERE PULMONARY INSUFFICIENCY. IN ADDITION, IT WAS MENTIONED THAT 14 FREESTYLE VALVES FROM A SEPARATE STUDY WERE EXPLANTED DUE TO NON-INFECTIVE AORTIC WALL RUPTURE. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17768 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R