BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADMIRAL XTREME

    MDR report key: 3030562 · Received April 2, 2013

    Report

    Report Number
    3004066202-2013-00037
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    December 12, 2013
    Report Date
    April 30, 2014
    Manufacturer
    INVATEC SPA
    Product Code
    LIT
    PMA / PMN Number
    K062809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PERFORATION. CONCLUSION: PERFORATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS AND CONCLUSION: INHERENT RISK OF PROCEDURE - (DISSECTION).

    Additional Manufacturer Narrative · 1

    RESULTS: STENOSIS. CONCLUSIONS: STENOSIS. (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, PHYSICIAN USED ONE ADMIRAL EXTREME STANDARD PTA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE SFA OF THE LEFT LEG. DEVICE WAS SUCCESSFUL; HOWEVER IT WAS REPORTED THAT DURING TREATMENT WITH THE ADMIRAL EXTREME BALLOON, A DISSECTION OCCURRED. DISSECTION WAS UNTREATED. INVESTIGATOR HAS NOT ASSESSED THE RELATEDNESS TO DEVICE OR PROCEDURE. THE PATIENT WAS DISCHARGED THE SAME DAY.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT SUFFERED A PERFORATION DURING INDEX PROCEDURE. THE PERFORATION WAS TREATED WITH POST DILATION BALLOONING FOR 5 MINUTES. INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE PATIENT IS REPORTED TO HAVE RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    THE CLINICAL EVENTS COMMITTEE ASSESSED THAT THE PREVIOUSLY REPORTED TARGET LESION REVASCULARIZATION WHICH TOOK PLACE APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE, WAS RELATED TO THE STUDY DEVICE BUT WAS NOT RELATED TO THE STUDY PROCEDURE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE RESTENOSIS OF THE LEFT SFA OCCURRED. THE PATIENT UNDERWENT REVASCUL ARIZATION OF THE TARGET VESSEL AND WAS TREATED WITH PTA AND ORBITAL ATHERECTOMY.

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED RESTENOSIS OF THE SFA WHICH OCCURRED 12 MONTHS POST INDEX PROCEDURE WAS RESOLVED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE SFA AND POPLITEAL WERE TREATED DURING THE PREVIOUSLY REPORTED REVASCULARIZATION APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE. INVESTIGATOR ASSESSED THE LEFT SFA RESTENOSIS EVENT TO BE NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134497 ADMIRAL XTREME CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT INVATEC SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention CLOPIDOGREL AND ASPIRIN.