BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 8041953 · Received November 6, 2018

    Report

    Report Number
    2025587-2018-02963
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    October 16, 2018
    Report Date
    May 8, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000017828
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: DALLAN LAP ET AL. PREDICTED CORONARY OCCLUSION AND IMPELLA SALVAGE DURING VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE REPLACEMENT. CARDIOVASC REVASC MED. 2019 MAR 29. PII: S1553-8389(19)30223-4. DOI: 10.1016/J.CARREV.2019.03.019. 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 · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION VIA LITERATURE REGARDING THIS (B)(6) FEMALE PATIENT WHO UNDERWENT VALVE-IN-VALVE (VIV) WITH A TRANSCATHETER AORTIC VALVE IMPLANT (TAVI). SHORTLY AFTER SUCCESSFUL DEPLOYMENT OF THE TAVI, CLOSURE OF THE LEFT MAIN (LM) CORONARY OSTIUM WAS OBSERVED FOLLOWED BY PROFOUND HYPOTENSION, ISCHEMIC CARDIOGENIC SHOCK AND CARDIO-RESPIRATORY ARREST IN PULSELESS ELECTRICAL ACTIVITY (PEA) RHYTHM. AN IMMEDIATE PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LM WAS PERFORMED. AFTER A FEW MINUTES OF PERSISTENT HEMODYNAMIC INSTABILITY A NON-MEDTRONIC MECHANICAL CIRCULATORY SUPPORT SYSTEM WAS IMPLANTED AND ANON-MEDTRONIC STENT PROTRUDING TO THE AORTA. THE PATIENT RECOVERED SPONTANEOUS CIRCULATION AND HEMODYNAMIC STABILIZATION, AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) WITHOUT MAJOR COMPLICATIONS. THREE DAYS LATER THE CONTROL ECHOCARDIOGRAM SHOWED GOOD VALVE FUNCTION AND NORMAL MYOCARDIAL CONTRACTILITY. AT ONE WEEK POST-PROCEDURE THE PATIENT WAS DISCHARGED.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE REMAINS IMPLANTED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, THE IMPLANTING PHYSICIAN DEPLOYED A PRE-PROCEDURAL STENT DUE TO CONCERN THAT THE LEFT MAIN CORONARY ARTERY WOULD BECOME OCCLUDED. DURING THE IMPLANT, AS THE VALVE WAS BEING DEPLOYED, THE LEFT MAIN CORONARY ARTERY BECAME OCCLUDED BY THE NATIVE LEAFLET. THE PATIENT'S BLOOD PRESSURE DROPPED AND CHEST COMPRESSIONS WERE INITIATED. A CORONARY STENT WAS DEPLOYED TO RESTORE FLOW. A TEMPORARY VENTRICULAR SUPPORT DEVICE WAS ALSO DEPLOYED IN THE LEFT VENTRICLE. THE PATIENT'S BLOOD PRESSURE AND HEART RHYTHM WERE RESTORED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883515 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-26-US 00763000017828

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention