BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 2991097 · Received March 6, 2013

    Report

    Report Number
    3004066202-2013-00025
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    June 25, 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

    (B)(4). RESULTS: REVASCULARIZATION.

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED AMPUTATION PERFORMED 24.5 MONTHS POST INDEX PROCEDURE WAS PERFORMED DUE TO WOUND HEALING DISORDER.

    Description of Event or Problem · 1

    DURING THE PREVIOUSLY REPORTED PROCEDURE APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE (NOT 24 MONTHS AS PREVIOUSLY REPORTED) THE PATIENT UNDERWENT AN ATHERECTOMY AND DCB. INVESTIGATOR INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE/ PROCEDURE. THE EVENT WAS RESOLVED. APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE AMPUTATION OF THE FIRST DIGIT ON THE RIGHT METATARSAL WAS PERFORMED DUE TO A WOUND HEALING DISORDER. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE/ PROCEDURE. THE EVENT IS RESOLVED. APPROXIMATELY 24.5 MONTHS POST INDEX PROCEDURE AMPUTATION OF THE RIGHT LIMB BELOW THE KNEE WAS PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS UNLIKELY RELATED TO THE STUDY DEVICE/ PROCEDURE. THE EVENT IS RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, THE PHYSICIAN USED AN AMPHIPRION DEEP PTA BALLOON CATHETER TO PERFORM REVASCULARIZATION OF THE RIGHT ANTERIOR TIBIAL ARTERY WITH NO ISSUE REPORTED; HOWEVER IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS LATER (APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE) THE PATIENT UNDERWENT PTA OF THE RIGHT ANTERIOR TIBIAL ARTERY DUE TO STENOSIS. IT WAS NOT ASSESSED IF THE EVENT WAS RELATED TO THE STUDY DEVICE. THE EVENT WAS RESOLVED. IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS LATER, THE PATIENT WAS RE-HOSPITALIZED DUE TO ATHEROSCLEROSIS OF THE EXTREMITIES ARTERIES. THE PATIENT IS REPORTED TO HAVE UNDERGONE SURGERY. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS PROBABLY RELATED TO THE STUDY DEVICE. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    THE INVESTIGATOR HAS ASSESSED THAT THE PTA WHICH OCCURRED APPROXIMATELY 23 MONTHS POST THE INDEX PROCEDURE WAS NOT RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96001 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY INVATEC SPA

    Patients

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