BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA CP

    MDR report key: 2994343 · Received March 4, 2013

    Report

    Report Number
    1220648-2013-00002
    Event Type
    Injury
    Date Received
    March 4, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 7, 2013
    Manufacturer
    ABIOMED EUROPE GMBH (GERMANY)
    Product Code
    KFM
    PMA / PMN Number
    K112892
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPELLA CP PUMP HAS NOT BEEN RETURNED TO ABIOMED FOR EVALUATION AND ANALYSIS AS IT IS AGAINST HOSPITAL POLICY TO REMOVE THE PRODUCT FROM THE HOSPITAL. THE MANUFACTURER WILL CONTINUE TO INVESTIGATE ALL REASONABLY OBTAINABLE SOURCES OF INFORMATION AND WILL PROVIDE RESULTS AND UPDATED CONCLUSIONS IN A SUPPLEMENTAL MEDWATCH REPORT. (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THAT THE PHYSICIAN WAS TREATING (B)(6) MALE PATIENT WITH SEVERE MISTRAL REGURGITATION AND PULMONARY HYPERTENSION. THE PHYSICIAN PLACED AN IMPELLA CP PUMP VIA THE PATIENT'S LEFT FEMORAL ARTERY. THE 14 FRENCH OSCOR SHEATH WAS PLACED WITHOUT DIFFICULTY. A DIAGNOSTIC CATHETER WITH THE AIR OF AN 0.035 WIRE WAS THEN PLACED ACROSS THE AORTIC VALVE AND ADVANCEMENT WAS STOPPED. THE 0.035 WIRE WAS THEN EXCHANGED WITH THE ABIOMED. 0.018 WIRE AND THE DIAGNOSTIC CATHETER WAS REMOVED, AND THE 0.018 WIRE PLACEMENT WAS CONFIRMED VIA FLUOROSCOPY TO BE IN THE VENTRICLE. THE IMPELLA CP CATHETER WAS THEN ADVANCED WITHOUT DIFFICULTY OVER-THE-WIRE ACROSS THE AORTIC VALVE TO THE LFT INTRA-VENTRICULAR SPACE. UNDER FLUOROSCOPY THE CATHETER APPEARED TO BE CORRECTLY POSITIONED. THE LEFT VENTRICLE WAS FOUND TO BE DE-COMPENSATED WITH MINIMAL INTRA-VENTRICULAR SPACE AND FILLING. DURING THE REMOVAL OF THE ABIOMED 0.018 WIRE, THE CATHETER WAS WITHDRAWN WITH THE WIRE, WITH MINIMAL RESISTANCE, BUT WAS UNKNOWINGLY BROUGHT DOWN TO THE LEVEL OF THE LEFT EXTERNAL ILIAC ARTERY. UPON VISUALIZATION UNDER FLUOROSCOPY THE CATHETER WAS FOUND TO BE FOLDED BACK UPON ITSELF, WITH THE WIRE ANCHORED IN THE CATHETER. THE PHYSICIAN DETERMINED THAT THE ARTERY REQUIRED CUT-DOWN FOR REMOVAL OF THE IMPELLA CP PUMP AND WIRE. THE ARTERY WAS REPAIRED BY PLACING A GRAFT FROM WHAT APPEARED THE EXTERNAL ILIAC TO THE COMMON FEMORAL. THE PLACEMENT OF AN IMPELLA LD5.0 WAS DISCUSSED, BUT DUE TO THE PATIENT'S PERIPHERAL ARTERY DISEASE, THE PLACEMENT OF AN IMPELLA LD5.0 WAS CONTRAINDICATED. IN ADDITION, A SHORT ARCH PREVENTED IMPELLA LD 5.0 PLACEMENT. AS A RESULT OF THE PATIENT'S ELEVATED PULMONARY PRESSURES AND DILATED RIGHT VENTRICLE, A DECISION WAS MADE TO PLACE AN ECMO. THE PATIENT WAS THEN TRANSPORTED TO ANOTHER FACILITY AND PLACED ON BIVAD SUPPORT. THE PATIENT WAS REPORTED TO BE DOING WELL, AND THERE HAVE BEEN NO INDICATION OF ANY ADDITIONAL ADVERSE AFFECTS TO THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91624 IMPELLA CP KFM ABIOMED EUROPE GMBH (GERMANY) IMPELLA CP 0070559

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention