BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 4566833 · Received March 4, 2015

    Report

    Report Number
    3004066202-2015-00086
    Event Type
    Death
    Date Received
    March 4, 2015
    Date of Event
    February 22, 2015
    Report Date
    November 20, 2015
    Manufacturer
    INVATEC TECHNOLOGY CENTER GMBH
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (DEATH). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DEATH). (B)(4).

    Additional Manufacturer Narrative · 1

    THE CEC ADJUDICATED THAT THE OCCLUSION WAS RELATED TO THE PROCEDURE, NOT RELATED TO THE DEVICE AND DRUG.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, FOUR IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETERS WERE USED, THREE TO TREAT THE LEFT SFA AND ONE TO TREAT THE LEFT POPLITEAL. DEVICES WERE SUCCESSFUL. APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED OCCLUSION OF THE LEFT AND RIGHT ILIOFEMORAL AND FEMOROPOPLITEAL AXES. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, PROCEDURE OR DRUG. THE PATIENT WAS TREATED WITH A THROMBENDARTERECTOMY BUT DIED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150847 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU INVATEC TECHNOLOGY CENTER GMBH 2D022001

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Death