BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 3223670 · Received July 12, 2013

    Report

    Report Number
    3004066202-2013-00117
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 28, 2013
    Report Date
    July 2, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE ¿ (HEMATOMA). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (HEMATOMA). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSIONS: (TVR). (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATOR'S ASSESSMENT OF THE PROCEDURE RELATIONSHIP WAS PREVIOUSLY INCORRECT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT SUFFERED AN ANEURYSM SPURIUM APPROX 12.5 MONTHS POST INDEX PROCEDURE. PATIENT WAS TREATED WITH HAEMATOMA EVACUATION AND HAEMODIALYSIS. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. IT IS REPORTED THAT THE EVENT WAS RESOLVED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PHYSICIAN USED THREE AMPHIRION DEEP PTA BALLOON CATHETERS TO TREAT A LESION LOCATED IN THE ANTERIOR TIBIAL ARTERY OF THE LEFT LEG. THE FIRST AND THIRD BALLOONS WERE SUCCESSFUL BUT A DISSECTION WAS REPORTED AFTER THE SECOND BALLOON. NO TREATMENT WAS REPORTED. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE THE PATIENT HAD A TARGET VESSEL REVASCULARIZATION OF THE LEFT ATA DUE TO RESTENOSIS. AN IN-PACT AMPHIRION PACLITAXEL-ELUTING PTA BALLOON CATHETER AND A NON-MEDTRONIC BALLOON WERE USED FOR TREATMENT. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS UNLIKELY TO BE RELATED TO THE STUDY DEVICE OR THE PROCEDURE. IT IS REPORTED THAT THE EVENT IS RESOLVED.

    Description of Event or Problem · 1

    INVESTIGATOR ASSESSED THAT THE ANEURYSM SPURIUM EVENT WAS HIGHLY PROBABLY RELATED TO THE STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323038 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention CLOPIDOGREL AND ASPIRIN