BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE SFA STENT

    MDR report key: 1480198 · Received July 15, 2009

    Report

    Report Number
    2953200-2009-00928
    Event Type
    Malfunction
    Date Received
    July 15, 2009
    Date of Event
    June 15, 2009
    Report Date
    June 15, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: DISSECTION, SEVERE DISEASE OF THE LEFT SFA WITH 60 TO 90% STENOSIS. EVALUATION: CONCLUSIONS: SEVERE DISEASE OF THE LEFT SFA WITH 60 TO 90% STENOSIS. INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    A 7MM DIAMETER X 150 MM LENGTH COMPLETE SE ILIAC STENT DELIVERY SYSTEM WAS SELECTED FOR INSERTION INTO A PATIENT FOR THE TREATMENT OF A 60 TO 90% STENOSED, SEVERELY DISEASED LESION OF THE LEFT SUPERFICIAL FEMORAL ARTERY. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT WHEN THE STENT WAS DEPLOYED, A DISSECTION WAS NOTED PROXIMAL TO THE STENT. THE PHYSICIAN ELECTED TO TREAT THE DISSECTION WITH A SECOND COMPLETE SE STENT. IT WAS REPORTED THAT THE PATIENT RECOVERED. THE INVESTIGATOR HAS INDICATED THAT THERE IS A POSSIBLE RELATION TO THE STUDY STENT AND INDICATED THAT THERE WAS A DEFINITE RELATION BETWEEN THE EVENT AND THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE SFA STENT FGE MEDTRONIC CARDIOVASCULAR NA V00173489

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR