BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADMIRAL XTREME

    MDR report key: 2931270 · Received January 28, 2013

    Report

    Report Number
    3004066202-2013-00007
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    November 20, 2012
    Report Date
    March 27, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSIONS: (RESTENOSIS REQUIRING MEDICAL INTERVENTION). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PREVIOUSLY REPORTED REVASCULARIZATION WAS PERFORMED ON (B)(6)-2012. IT WAS ALSO REPORTED THAT DURING THIS REVASCULARIZATION THE TIBIAL-PERONEAL TRUNK ARTERY (TPT) WAS TREATED INSTEAD OF THE POSTERIOR TIBIAL ARTERY.

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED REVASCULARIZATION PERFORMED APPROXIMATELY 19 MONTHS POST PROCEDURE TREATED THE POSTERIOR TIBIAL ARTERY, SUPERFICIAL FEMORAL ARTERY AND THE TIBIO-PERONEAL TRUNK ARTERY. A PACIFIC XTREME PTA BALLOON CATHETER WAS USED TO TREAT THE POPLITEAL ARTERY.

    Description of Event or Problem · 1

    AN ADMIRAL XTREME PTA BALLOON CATHETER WAS USED TO TREAT A LESION IN THE POPLITEAL ARTERY OF THE LEFT LIMB DURING A REVASCULARIZATION PROCEDURE. AMPUTATION OF THE THIRD DIGIT ON THE LEFT TOE WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 6 MONTHS POST PROCEDURE. IT WAS REPORTED THAT RE-STENOSIS OF POPLITEAL OCCURRED AND REVASCULARIZATION WAS PERFORMED APPROXIMATELY 5 WEEKS LATER. PATIENT DEATH WAS REPORTED TO HAVE OCCURRED DUE TO CARDIAC ARREST APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37451 ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| H| R ASPIRIN