BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADMIRAL XTREME PTA BALLOON CATHETER

    MDR report key: 3840189 · Received May 30, 2014

    Report

    Report Number
    3004066202-2014-00082
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    August 22, 2014
    Report Date
    October 9, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (ACUTE RE-OCCLUSION NECESSITATING SURGICAL INTERVENTION. ) EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (ACUTE RE-OCCLUSION NECESSITATING SURGICAL INTERVENTION). (B)(4).

    Additional Manufacturer Narrative · 1

    CODES CORRECTED.

    Additional Manufacturer Narrative · 1

    INHERENT RISK OF PROCEDURE (OCCLUSION) (B)(4).

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED EVENT OF THROMBOTIC OCCLUSION OF THE FEMORO-POPLITEAL BYPASS ON THE RIGHT LIMB APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE IS REPORTED TO BE RESOLVED.

    Description of Event or Problem · 1

    TWO ADMIRAL XTREME PTA BALLOON CATHETERS AND ONE PACIFIC PLUS PTA BALLOON CATHETER WERE USED TO TREAT THE RIGHT SFA DUE TO CLAUDICATION. APPROXIMATELY 5 MONTHS LATER RE-OCCLUSION OF THE RIGHT SFA AND POPLITEAL WAS REPORTED. THIS WAS TREATED WITH SURGICAL INTERVENTION IN THE FORM OF A FEMORO-POPLITEAL BYPASS. OUTCOME IS REPORTED AS RESOLVED.

    Description of Event or Problem · 1

    APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE THE PATIENT SUFFERED THROMBOTIC OCCLUSION OF THE FEMORO-POPLITEAL BYPASS ON THE RIGHT LEG (TARGET LIMB) WHICH WAS TREATED WITH A RIGHT POSTERIOR TIBIAL FEMORAL BYPASS. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    THE CLINICAL EVENTS COMMITTEE ADJUDICATED THAT THE PREVIOUSLY REPORTED SUBOCCLUSION OF THE RIGHT SFA AND POPLITEAL WHICH OCCURED 12 MONTHS POST INDEX PROCEDURE WAS RELATED TO THE STUDY DEVICE AND WAS NOT RELATED TO THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318439 ADMIRAL XTREME PTA BALLOON CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention