BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 5123038 · Received October 2, 2015

    Report

    Report Number
    3004066202-2015-00436
    Event Type
    Injury
    Date Received
    October 2, 2015
    Date of Event
    August 18, 2015
    Report Date
    June 17, 2016
    Manufacturer
    INVATEC TECHNOLOGY CENTER GMBH
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE CEC ADJUDICATED THE PREVIOUSLY REPORTED STENOSIS OF RIGHT SFA/ POA AS RELATED TO THE DEVICE, NOT RELATED TO THE STUDY PROCEDURE OR DRUG.

    Additional Manufacturer Narrative · 1

    THE PREVIOUSLY REPORTED PERIPHERAL ARTERIAL OCCLUSIVE DISEASE WHICH OCCURRED APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE TERM HAS BEEN UPDATED TO STENOSIS OF RIGHT SFA/ POA. AN AMPHIRION BALLOON, 2 IN.PACT BALLOONS AND NON-MEDTRONIC STENTING WERE USED DURING THE REVASCULARIZATION.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE 3 IN.PACT ADMIRAL PACLITAXEL ELUTING PTA BALLOON CATHETERS WERE USED TO TREAT THE RIGHT DISTAL SFA TO POPLITEAL. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE PATIENT SUFFERED PERIPHERAL ARTERIAL OCCLUSIVE DISEASE (PAOD) AND REVASCULARIZATION WAS CARRIED OUT USING PTA, DEB AND STENT. PATIENT RECOVERED. INVESTIGATOR ASSESSED THAT THE EVENT IS NOT RELATED TO THE STUDY DEVICE, PROCEDURE OR PACLITAXEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653657 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU INVATEC TECHNOLOGY CENTER GMBH 2D016911

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention