BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE STENT SYSTEM

    MDR report key: 1595186 · Received February 3, 2010

    Report

    Report Number
    2953200-2010-00137
    Event Type
    Injury
    Date Received
    February 3, 2010
    Date of Event
    November 12, 2009
    Report Date
    January 8, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K062264
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) EVALUATION RESULTS: (REVASCULARIZATION).

    Description of Event or Problem · 1

    THE PT HAD 2 COMPLETE SE STENTS IMPLANTED, 1 STENT IMPLANTED TO THE POPLITEAL ARTERY (PPA) AND 1 IMPLANTED TO THE MID/DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) (MFR REPORT # 2953200-2009-01786). BOTH LESIONS ARE REPORTED TO BE SEVERELY CALCIFIED. THE STENTS WERE DEPLOYED SUCCESSFULLY. ONE MONTH POST INDEX PROCEDURE, THE PT REQUIRED HOSPITALIZATION OF CARDIAC ISCHEMIA. VASCULAR INTERVENTION WAS PERFORMED. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS NOT RELATED TO THE STUDY DEVICE. APPROX 6.5 MONTHS POST INDEX PROCEDURE, THE PT SUFFERED SEVERE CLAUDICATION IN THE RIGHT CALF/BUTTOCK. THE PT WAS HOSPITALIZED AND TARGET VESSEL REVASCULARIZATION WAS PERFORMED. THE PT IS CONTINUING WITH TREATMENT. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS RELATED TO THE STUDY STENT. COMPLETE SE IS NOT APPROVED FOR USE IN THE U.S. FOR SFA INDICATION, BUT IS SIMILAR TO COMPLETE SE WHICH IS APPROVED FOR BILIARY INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR NA V00164466

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention ASPIRIN 24 HRS PRIOR TO EVENT. | THE PT WAS TAKING CLOPIDOGREL &.| THE PT WAS TAKING CLOPIDOGREL &| ASPIRIN 24 HRS PRIOR TO EVENT.