BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 7129778 · Received December 19, 2017

    Report

    Report Number
    1220648-2017-00118
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    November 27, 2017
    Report Date
    November 28, 2017
    Manufacturer
    ABIOMED EUROPE GMBH
    Product Code
    OJE
    UDI-DI
    00813502010022
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPELLA RP WAS RETURNED FOR EVALUATION, WITH THE CANNULA DETACHED FROM THE MOTOR HOUSING. DURING THE EVALUATION THE SILICONE WAS FOUND OVER THE DELO BEAD THAT WAS LINED UP WITH THE DIFFERENTIAL PRESSURE SENSOR, AND THE HYDEX RING WAS DEFORMED. WHILE THE PARTICULAR CIRCUMSTANCES OF THIS FAILURE IS UNKNOWN, SILICONE CONTAMINATION AND DEFORMATION OF THE HYDEX RING IS KNOWN TO REDUCE THE STRENGTH OF THE PUMP HOUSING/CANNULA BOND. THIS COULD PREDISPOSE IT TO FAILURE UNDER THE STRESS APPLIED DURING PUMP EXPLANT. IN THIS INSTANCE IS NOT CLEAR WHETHER THE HYDEX RING DEFORMATION OCCURRED PRIOR TO THE INTERVENTION TO EXTRACT THE CANNULA FROM THE PATIENT'S ILIAC VEIN. (B)(4) WAS CREATED TO ADDRESS RP CANNULA DETACHMENTS. IN CONCLUSION THE ROOT CAUSE OF THE CANNULA DETACHMENT WAS UNABLE TO BE DETERMINED, BUT SILICONE CONTAMINATION MAY HAVE CONTRIBUTED TO THE FAILURE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE IMPELLA CP PUMP PRODUCT AND DATA LOGS WERE RETURNED FOR ANALYSIS, HOWEVER THE INVESTIGATION IS ON-GOING AT THIS TIME. A SUPPLEMENTAL MEDWATCH WILL BE COMPLETED UPON INVESTIGATION COMPLETION. (B)(4).

    Description of Event or Problem · 1

    ITALIAN COMPLAINANT REPORTED THAT ON (B)(6) 2017 AN IMPELLA RP WAS PLACED IN A (B)(6) FEMALE PATIENT. THE PATIENT WAS REPORTED TO HAVE BEEN SUCCESSFULLY SUPPORTED, PER THE CASE INFORMATION RELAYED THROUGH EUROPEAN DISTRIBUTOR. ON (B)(6) 2017, DAY 9 OF PATIENT SUPPORT, THE PATIENT WAS WEANED FROM THE RP DEVICE. THE PHYSICIAN TRIED TO REMOVE THE DEVICE, BUT DAMAGED THE CATHETER IN HIS ATTEMPT AND FRACTURED IT INTO TWO PIECES DURING REMOVAL. AS A RESULT, THE DETACHED PORTION OF THE CANNULA AND PUMP REMAINED IN THE PATIENT'S ILIAC VEIN, WHICH NECESSITATED SURGICAL REMOVAL OF THE PORTION OF THE CANNULA. THE DETACHED PORTION OF THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE ILIAC VEIN. THE PATIENT WAS REPORTED TO BE IN CARDIOGENIC SHOCK DURING THE SURGICAL REMOVAL OF THE DEVICE. AN ECMO WAS PLACED IN THE PATIENT FOR HEMODYNAMIC AND RESPIRATORY SUPPORT SUBSEQUENT TO IMPELLA RP EXPLANT. THE PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911227 IMPELLA RP RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED EUROPE GMBH IMPELLA RP 1273471 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention