BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RECOVER LP 2.5 PERC CARDIAC SUPPORT

    MDR report key: 3023811 · Received March 21, 2013

    Report

    Report Number
    1220648-2013-00004
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    October 12, 2012
    Report Date
    March 5, 2013
    Manufacturer
    ABIOMED EUROPE GMBH (GERMANY)
    Product Code
    KFM
    PMA / PMN Number
    K063723
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING EVAL. UPON THE CONCLUSION OF THE EVAL, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE CLINICIANS WERE TREATING (B)(6) MALE PT WHO HAD PRESENTED ON (B)(6) 2013 IN THE EMERGENCY ROOM WITH SHORTNESS OF BREATH AND TROPONINS. THE CARDIAC CATHETER REVEALED SEVERE 3X VESSEL DISEASE. AN INTRA-AORTIC BALLOON (IABP) WAS PLACED FROM THE RIGHT GROIN AND AN IMPELLA LP 2.5 PUMP WAS PERCUTANEOUSLY PLACED. THE PT WAS THEN PREPPED FOR OPEN HEART SURGERY, DURING WHICH "A FEW ISSUES AS THEY RAISED HIS LEG DURING THE PREP" OCCURRED. ON THE NIGHT OF (B)(6) 2013, THE PT HAD DIFFICULTIES WITH HYPERCALCEMIA, WHICH LED TO BUNDLE BRANCH BLOCK AND HYPOVOLEMIA AND HIS CARDIAC INDEX AND OUTPUT BOTTOMED OUT. THE SURGEONS PERFORMED DIRECT MANUAL HEART MASSAGE. THE IMPELLA WAS HIS ONLY SOURCE OF CARDIAC OUTPUT. THE PT IMPROVED SIGNIFICANTLY. HIS INDEX WAS NOW 3.3 AND HIS OUTPUT WAS IN THE MID 6 L/M AND WAS DOING WELL. THE PT'S THROMBOLYSIS ALSO CLEARED UP. ON (B)(6) 2013, THE PT'S HEART SHOWED SIGNS OF IMPROVEMENT. THE IABP WAS REMOVED, BUT THE IMPELLA COULD NOT BE REMOVED, DUE TO THE PT'S FULL DEPENDENCY ON IMPELLA TO SUSTAIN LIFE. A CARDIOPULMONARY BYPASS ALSO HAD TO BE EMPLOYED DURING SURGERY. THE PT WENT TO THE OPERATING ROOM (OR) WHERE HIS CHEST WAS "CLEANED OUT AND CLOSED WITH SIRES." WHILE IN THE OPERATING ROOM, THE ANESTHESIOLOGIST CHECKED IMPELLA PLACEMENT WITH TRANSESOPHAGEAL (TEE). PLACEMENT WAS GOOD. IMPELLA POSITION WAS ALSO VISUALIZED WITH CHEST X-RAY, AND PLACEMENT HAD NOT CHANGED. POST-PROCEDURE, THE PT WAS STILL FULLY DEPENDENT ON IMPELLA AND COMPROMISE OF THE LEFT LEG CIRCULATION WAS NOTED. THE LEFT LEG ISCHEMIA PROGRESSED, BUT THE PHYSICIAN REPORTED THAT DESPITE THE ISCHEMIA, THE PT WAS DEPENDENT ON THE IMPELLA LP 2.5 SUPPORT, AND WOULD HAVE DIED IF IT HAD BEEN REMOVED. THE DECISION WAS MADE TO CONTINUE THE IMPELLA SUPPORT. THE PT SUBSEQUENTLY HAD TO HAVE HIS LEFT LEG AMPUTATED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117639 IMPELLA RECOVER LP 2.5 PERC CARDIAC SUPPORT KFM ABIOMED EUROPE GMBH (GERMANY) LP2.5 069151

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention