BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 3220919 · Received July 11, 2013

    Report

    Report Number
    3004066202-2013-00114
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    June 10, 2013
    Report Date
    August 18, 2015
    Manufacturer
    INVATEC SPA
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OUTCOME OF THE PREVIOUSLY REPORTED WORSENING PAD OF THE RIGHT LIMB APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE IS RESOLVED. THE OUTCOME OF THE PREVIOUSLY REPORTED WORSENING PAD OF THE LEFT PTA APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE IS RESOLVED. THE OUTCOME OF THE PREVIOUSLY REPORTED WORSENING PAD OF THE LEFT A PLANTARIS APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE IS RESOLVED. THE OUTCOME OF THE PREVIOUSLY REPORTED WORSENING GANGRENE AND PAD OF THE LEFT LIMB APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE IS RESOLVED. THE OUTCOME OF THE PREVIOUSLY REPORTED NECROSIS RESULTING IN AMPUTATION OF THE RIGHT UPPER LIMB APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE IS RESOLVED. THE INVESTIGATOR ASSESSED THE PREVIOUSLY REPORTED WORSENING OF PAD IN THE LEFT LIMB AND WORSENING OF PAD IN THE LEFT LIMB WHICH OCCURRED APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE AS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. OUTCOME IS UNRESOLVED. THE OUTCOME OF THE PREVIOUSLY REPORTED STENOSIS OF THE LEFT POPLITEAL APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE IS RESOLVED. THE OUTCOME OF THE PREVIOUSLY REPORTED OCCLUSION OF THE LEFT INFRAPOPLITEAL ARTERIES (ATA AND A FIB) LEFT APPROXIMATELY 24 MONTHS PO ST INDEX PROCEDURE IS RESOLVED THE OUTCOME OF THE PREVIOUSLY REPORTED OCCLUSION OF THE ATP LEFT APPROXIMATELY 26 MONTHS POST INDEX PROCEDURE IS UNRESOLVED. THE OUTCOME OF THE PREVIOUSLY REPORTED ACUTE WORSENING OF PAD LEFT APPROXIMATELY 36 MONTHS POST INDEX PROCEDURE IS RESOLVED. THE PATIENT WAS TREATED WITH NON-MEDTRONIC PTA.

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS AND CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (STENOSIS). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN USED AN AMPHIRION DEEP PTA BALLOON CATHETER DURING A REVASCULARIZATION OF THE LEFT POSTERIOR TIBIAL ARTERY. OCCLUSION OF THE BTK VESSELS (ANTERIOR TIBIAL ARTERY, POSTERIOR TIBIAL ARTERY AND DORSALIS PEDIS ARTERY) OF THE LEFT LEG WAS REPORTED TO HAVE OCCURRED APPROXIMATELY 8 MONTHS LATER AND WAS TREATED WITH A PTA. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE / PROCEDURE. OUTCOME OF THE EVENT IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319515 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention