BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 3231797 · Received July 17, 2013

    Report

    Report Number
    3004066202-2013-00120
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    July 12, 2013
    Report Date
    October 24, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSIONS: PREDISPOSED EVENT (WORSENING PERIPHERAL ARTERIAL DISEASE RIGHT LIMB). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE TWO MEDTRONIC DRUG ELUTING BALLOONS WERE USED TO TREAT A LESION LOCATED IN THE POSTERIOR TIBIAL ARTERY OF THE RIGHT LEG. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE THE PATIENT HAD A NON-TARGET VESSEL REVASCULARIZATION OF THE RIGHT ANTERIOR TIBIAL ARTERY DUE TO WORSENING PAD OF THE RIGHT LIMB. THE RIGHT ANTERIOR TIBIAL ARTERY WAS TREATED WITH AN AMPHIRION DEEP PTA BALLOON CATHETER. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE AMPUTATION OF DIGIT 1 RIGHT TOE WAS REQUIRED DUE TO PAIN DIG 1 PEDIS DEXT FOLLOWING GANGRENE DIG 1 PEDIS DEXT. THE PATIENT WAS ALSO TREATED WITH MEDICATION. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. IT IS REPORTED THAT THE EVENT WAS RESOLVED. APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE AMPUTATION OF DIGIT II RIGHT TOE WAS REQUIRED DUE TO GANGRENE DIG II PEDIS DEXT. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. IT IS REPORTED THAT THE EVENT WAS RESOLVED. APPROXIMATELY 25 MONTHS POST INDEX PROCEDURE THE PATIENT HAD A TARGET REVASCULARIZATION OF THE RIGHT ANTERIOR TIBIAL ARTERY DUE TO WORSENING PERIPHERAL ARTERIAL DISEASE RIGHT LIMB. THE RIGHT ANTERIOR TIBIAL ARTERY WAS TREATED WITH A NON-MEDTRONIC BALLOON. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. IT IS REPORTED THAT THE EVENT WAS RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT APPROXIMATELY 26 MONTHS POST INDEX PROCEDURE AMPUTATION OF DIGIT III RIGHT TOE WAS REQUIRED DUE TO GANGRENE. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. IT IS REPORTED THAT THE EVENT WAS RESOLVED. APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE AMPUTATION OF DIGIT IV <(>&<)> V RIGHT TOE WAS REQUIRED DUE TO GANGRENE. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. IT IS REPORTED THAT THE EVENT WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331013 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R CLOPIDOGREL AND ASPIRIN.