BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 5064523 · Received September 9, 2015

    Report

    Report Number
    3004066202-2015-00404
    Event Type
    Death
    Date Received
    September 9, 2015
    Date of Event
    December 3, 2014
    Report Date
    September 1, 2015
    Manufacturer
    INVATEC SPA
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PHYSICIAN USED FOUR IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE PROX, MID AND DISTAL SFA AND POP 1 OF THE RIGHT LEG. DEVICES WERE SUCCESSFUL. APPROX 15 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED. DEATH WAS OF UNKNOWN ORIGIN, BUT ASSUMED TO BE A CONSEQUENCE OF AORTAL DISSECTION OR PULMONARY EMBOLISM. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, PROCEDURE OR DRUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596451 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU INVATEC SPA 2E023710

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Death