BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPELLA RP

    MDR report key: 6190639 · Received December 20, 2016

    Report

    Report Number
    1220648-2016-00044
    Event Type
    Death
    Date Received
    December 20, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    ABIOMED, INC
    Product Code
    OJE
    UDI-DI
    00813502010022
    PMA / PMN Number
    P1400003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS INVOLVED IN THIS EVENT WERE DISCARDED BY THE USER SUBSEQUENT TO THE EVENT. THE MANUFACTURER WILL CONTINUE TO INVESTIGATE ALL REASONABLE OBTAINABLE SOURCE INFORMATION, AND WILL PROVIDE THEM ON A SUPPLEMENTAL MEDWATCH REPORT IF THEY BECOME AVAILABLE. DEVICE DISCARDED BY USER.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT ON (B)(6) 2016 A (B)(6) FEMALE PATIENT WITH A HISTORY OF INDETERMINATE STRESS ECHO, PRESENTED TO THE EMERGENCY ROOM WITH CARDIAC PAIN. AN EKG WAS PERFORMED WHICH REVEALED NON-SPECIFIC T-WAVE ELEVATION CHANGES, AND POSSIBLE APICAL HYPOKINESIS. THE PATIENT FURTHER PRESENTED WITH ATRIAL FIBRILLATION (AFIB) AND A VASO-VAGAL EVENT WITH CHEST PAIN. VENTRICULAR SEPTAL DEFECT CLOSURE SURGERY WAS PERFORMED. THE PATIENT THEN WENT INTO CARDIOGENIC SHOCK WHILE BEING SUPPORTED WITH AN INTRA-AORTIC BALLOON PUMP AND WHILE BEING ADMINISTERED WITH MAXIMUM PRESSORS AND INOTROPES. THE PATIENT WAS THEN BROUGHT INTO THE CARDIAC CARE LABORATORY FOR AN EMERGENT IMPELLA RP PLACEMENT, AS THERE WERE ESCALATING PULMONARY BLOOD PRESSURES. THE PATIENT'S HEMODYNAMICS WERE EVALUATED AND RESULTED IN AN IMPELLA CP ALSO BEING PLACED. THE PATIENT WAS SUCCESSFULLY SUPPORTED FOR 22 HOURS, AS THE PHYSICIAN PLANNED TO CONTINUE TO ALLOW THE HEART TO REST., AND THEN TO WEAN THE PRESSORS, AS TOLERATED. THE FOLLOWING EVENING DURING THE PHYSICIAN'S ATTEMPT TO REPOSITION THE IMPELLA RP THE RIGHT VENTRICLE WAS PERFORATED. THE PATIENT CODED AND THE PATIENT'S CHEST WAS IMMEDIATELY OPENED IN AN ATTEMPT TO REPAIR THE RV PERFORATION, BUT THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839131 IMPELLA RP PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE OJE ABIOMED, INC IMPELLA RP 1239146 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death IMPELLA CP