BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADMIRAL XTREME

    MDR report key: 2991089 · Received March 6, 2013

    Report

    Report Number
    3004066202-2013-00024
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    July 3, 2012
    Report Date
    June 25, 2013
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION 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

    THE INVESTIGATOR HAS ASSESSED THAT THE PREVIOUSLY REPORTED AMPUTATION WHICH OCCURRED APPROXIMATELY 24.5 MONTHS POST INDEX PROCEDURE WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE, THE PHYSICIAN USED AN ADMIRAL XTREME PTA BALLOON CATHETER TO PERFORM REVASCULARIZATION OF THE SFA OF THE RIGHT LEG WITH NO ISSUE REPORTED. HOWEVER IT WAS REPORTED THAT APPROXIMATELY 1 MONTHS AND 4 MONTHS LATER, AMPUTATION OF DIGIT 4 AND 5 WAS REQUIRED DUE TO NECROSIS AND WOUND HEALING DISORDER. IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS POST PROCEDURE, ROTAREX, THROMBECTOMY AND STENTING OF THE SFA WAS REQUIRED DUE TO OCCLUSION. INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. PATIENT IS REPORTED TO BE RECOVERED. IT WAS REPORTED THAT, APPROXIMATELY 11 MONTHS POST PROCEDURE (APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE), THE PATIENT UNDERWENT AN AMPUTATION OF THE RIGHT BIG TOE AND CUT OF 5TH METATARSAL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE EVENT WAS RESOLVED. IT WAS REPORTED THAT, FEW DAYS LATER THE PATIENT UNDERWENT STENTING OF THE RIGHT SFA DUE TO STENOSIS. A COMPLETE SE STENT AND ANOTHER BRAND BALLOON WERE USED FOR TREATMENT. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE EVENT WAS RESOLVED. THE EVENT WAS RESOLVED. IT WAS REPORTED THAT 4 MONTHS LATER (APPROXIMATELY 24 MONTHS POST INDEX PROCEDURE) 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95781 ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA

    Patients

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