BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO TRANSCATHETER AORTIC VALVE

    MDR report key: 11777620 · Received May 5, 2021

    Report

    Report Number
    2025587-2021-01442
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    May 16, 2020
    Report Date
    May 5, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MCKINNEY AR, ET AL. TRANSCATHETER AORTIC VALVE REPLACEMENT IN A PEDIATRIC PATIENT WITH A HISTORY OF CONGENITAL HEART DISEASE AND RECENT POST-PROCEDURE DECOMPENSATION. J CARDIOTHORAC VASC ANESTH. 2020 DEC;34(12):3385-3389. DOI: 10.1053/J.JVCA.2020.05.002. EPUB 2020 MAY 16. 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. INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE CASE REPORT REGARDING A (B)(6) MALE PATIENT (WEIGHT 30.8 KG) WITH A HISTORY OF CONGENITAL HEART DISEASE, MULTIPLE CARDIAC SURGICAL PROCEDURES, AND COMPLETE HEART BLOCK WITH PACEMAKER DEPENDENCE WHO UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A 29 MM MEDTRONIC EVOLUT PRO (UNIQUE DEVICE IDENTIFIER NUMBER NOT PROVIDED) AS A BRIDGE TO FUTURE HEART TRANSPLANTATION. PRIOR TO VALVE DEPLOYMENT, TRANSESOPHAGEAL ECHOCARDIOGRAPHY EXHIBITED SEVERE AORTIC INSUFFICIENCY AND BIVENTRICULAR FAILURE. VASOPRESSIN AND EPINEPHRINE BOLUSES AND INFUSIONS WERE ADMINISTERED. WITH PACING AND VALVE DEPLOYMENT, THE PATIENT DEVELOPED WORSENING VENTRICULAR FAILURE AND HYPOTENSION, THEN CARDIAC ARREST OCCURRED, WHICH REQUIRED CARDIOPULMONARY RESUSCITATION. APPROXIMATELY EIGHT MINUTES OF CHEST COMPRESSIONS WERE PERFORMED, WITH MULTIPLE BOLUSES OF EPINEPHRINE AND VASOPRESSIN, BEFORE SPONTANEOUS CIRCULATION RETURNED. POST-OPERATIVELY, THE PATIENT REMAINED INTUBATED FOR TRANSFER TO THE INTENSIVE CARE UNIT AND WAS EXTUBATED SEVERAL HOURS AFTER THE PROCEDURE. ONE DAY AFTER TAVR, THE PATIENT HAD CARDIAC ARREST DUE TO UNSTABLE VENTRICULAR TACHYCARDIA. ADVANCED CARDIOVASCULAR LIFE SUPPORT PROTOCOL WAS INITIATED WITH CARDIOVERSION ADMINISTERED. THE PATIENT DETERIORATED TO PULSELESS ELECTRICAL ACTIVITY BEFORE SPONTANEOUS CIRCULATION RETURNED. BEDSIDE TRANSTHORACIC ECHOCARDIOGRAPHY WAS PERFOR MED WITH NO VALVULAR OR CARDIAC PATHOLOGY TO EXPLAIN THIS POST-OPERATIVE ARREST. BASED ON THE PATIENT¿S POTASSIUM LEVEL OF 2.8 MILLIMOLES PER LITER, THE AUTHORS ATTRIBUTED THIS ARREST TO ELECTROLYTE ABNORMALITIES. ULTIMATELY, THE PATIENT WAS DISCHARGED WITH NO LONG-TERM EFFECTS. AT ONE-MONTH FOLLOW-UP, THE PATIENT REPORTED RELIEF OF HEART FAILURE SYMPTOMS AND WAS BACK IN SCHOOL FULL TIME. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673932 EVOLUT PRO TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION EVOLUTPRO-29

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| R