BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA RP

    MDR report key: 7468267 · Received April 27, 2018

    Report

    Report Number
    1220648-2018-00027
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    March 29, 2018
    Report Date
    March 29, 2018
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA RP AND THE 23FR OSCOR INTRODUCER SHEATHS WERE RETURNED FOR EVALUATION. THE RETURNED OSCOR INTRODUCER SHEATHS WERE ANALYZED. UPON CLOSE EXAMINATION OF THE VALVES FROM A TOP SIDE PERSPECTIVE, A SLIGHT CUT (TEAR) ON ONE HALF OF THE VALVE HUB WAS SEEN IN BOTH OF THE INTRODUCERS. THE CAUSE OF BLEEDING WAS DAMAGE MOST LIKELY INCURRED AS A RESULT OF OFF-CENTERED INSERTION OF THE DILATOR THROUGH THE OSCOR SHEATH. THIS MAY HAVE LED TO BLEEDING FROM THE INTRODUCER VALVE. INTERNAL REFERENCE: SPR 18-0367

    Additional Manufacturer Narrative · 1

    THE IMPELLA RP AND PEEL-AWAY SHEATHS HAVE NOT YET BEEN RETURNED FOR EVALUATION. AT THIS TIME THERE IS NO DEFINITIVE INFORMATION INDICATING THAT THE INABILITY TO PLACE THE IMPELLA RP WAS THE RESULT OF ANY ISSUE WITH THE DEVICE. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT (B)(6) YEAR OLD FEMALE PATIENT WAS IN A SLOWLY DECOMPENSATING CONDITION, AND WAS IN RIGHT HEAR FAILURE. A SWAN WAS PLACED IN THE PATIENT VIA THE RIGHT FEMORAL VEIN, BUT THERE WAS SOME INITIAL DIFFICULTY EXPERIENCED BY THE PHYSICIAN WHEN PLACING THE SWAN INTO THE LEFT PULMONARY ARTERY (LPA). THE PHYSICIAN THEN ATTEMPTED TO PLACE AN IMPELLA RP. WHEN ADVANCING THE PUMP OVER THE WIRE THE DEVICE WOULD NOT MAKE THE TURN INTO THE PULMONARY ARTERY (PA). AN 0.035 AMPLATZ WIRE WAS PLACED AS A BUDDY WIRE, BUT THIS WAS NOT SUCCESSFUL IN MAKING THE TURN INTO THE PA. DURING THE 35 MINUTE ATTEMPT TO PLACE THE IMPELLA RP, PATIENT BLEEDING OCCURRED FROM THE PEEL-AWAY SHEATH VALVE. TWO UNITS OF REPLACEMENT BLOOD WAS ADMINISTERED TO THE PATIENT AS A RESULT OF THE PRESSURES DROPPING. THE SHEATH WAS EXCHANGED FOR ANOTHER RP PEEL-WAY SHEATH, BUT THE SAME ISSUE OCCURRED, AND THE PUMP WOULD NOT MAKE THE TURN INTO THE PA. IT WAS DECIDED TO ABORT THE IMPELLA RP PLACEMENT, AS A RESULT OF THE PATIENT'S CARDIAC ANATOMY. THE PHYSICIAN THEN PLACED A TANDEM HEART IN THE PATIENT VIA THE RIGHT INTERNAL JUGULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311415 IMPELLA RP RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE OJE ABIOMED EUROPE GMBH IMPELLA RP 1250295 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention