BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP

    MDR report key: 3091019 · Received May 3, 2013

    Report

    Report Number
    3004066202-2013-00069
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    July 11, 2012
    Report Date
    April 8, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSION: (RESTENOSIS REQUIRING REINTERVENTION). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE ONE AMPHIRION DEEP PTA BALLOON CATHETER AND ONE PACIFIC XTREME PTA BALLOON CATHETER WERE USED FOR THE TREATMENT OF THE PERONEAL ARTERY AND TWO AMPHIRION DEEP PTA BALLOON CATHETERS WERE USED FOR THE TREATMENT OF THE ANTERIOR TIBIAL ARTERY OF THE RIGHT LEG. APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE THE PATIENT PRESENTED WITH WORSENING OF PERIPHERAL ARTERY DISEASE IN THE RIGHT LIMB AND PTA WAS PERFORMED WITH AN AMPHIRION DEEP PTA BALLOON CATHETER. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE DEVICE WAS SUCCESSFUL; HOWEVER, IT WAS REPORTED THAT DURING REVASCULARIZATION, A DISSECTION OCCURRED. APPROXIMATELY 3.5 MONTHS POST INDEX PROCEDURE AMPUTATION OF D1 RIGHT WAS REQUIRED DUE TO WOUND HEALING DISORDER. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. PATIENT RECOVERED. REVASCULARIZATION WITH PTA AND STENTING OF THE RIGHT ANTERIOR TIBIAL ARTERY WAS PERFORMED AGAIN APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE DUE TO STENOSIS. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194850 AMPHIRION DEEP CATHETER, PERCUTANEOUS DQY INVATEC SPA 1C025086

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention CLOPIDOGREL AND ASPIRIN.