BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5 PUP

    MDR report key: 9394847 · Received December 2, 2019

    Report

    Report Number
    1220648-2019-00266
    Event Type
    Injury
    Date Received
    December 2, 2019
    Date of Event
    November 8, 2019
    Report Date
    December 2, 2019
    Manufacturer
    ABIOMED EUROPE GMBH
    Product Code
    OZD
    UDI-DI
    4260113630419
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DISCARDED BY CUSTOMER. THE IMPELLA 5.5 PUMP WAS DISCARDED BY THE CUSTOMER THEREFORE A FAILURE ANALYSIS INVESTIGATION CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED A (B)(6) YEARS OLD WHITE MALE PATIENT HAD IMPELLA 5.5 PUMP INSERTED IN THE RIGHT AXILLARY WITH DIFFICULTY DUE TO VASCULAR ANATOMY AND POOR VISION ON FLUOROSCOPY IN THE OPERATING ROOM (OR). THE PHYSICIAN DECIDED TO STOP REPOSITIONING ATTEMPTS IN THE OR AND SENT THE PATIENT TO THE INTENSIVE CARE UNIT (ICU) TO OPTIMIZE POSITION UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE). THE TEAM FAILED TO REPOSITION THE PUMP; UNDER ECHOCARDIOGRAM (ECHO) INLET CAGE WAS VISUALLY ENTANGLED WITH THE PAPILLARY MUSCLE. AS A RESULT, VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) WAS ADDED, THE NEXT DAY A LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS IMPLANTED, AND BOTH THE IMPELLA 5.5 AND VA-ECMO WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188955 IMPELLA 5.5 PUP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, OZD ABIOMED EUROPE GMBH IMPELLA 5.5 PUMP 550 SET, EU 1422474 4260113630419

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention