BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE PERIPHERAL STENT SYSTEM

    MDR report key: 1876012 · Received October 15, 2010

    Report

    Report Number
    2953200-2010-01974
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    April 11, 2010
    Report Date
    April 17, 2012
    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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). (REVASCULARIZATION).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE ONE COMPLETE SE SFA PERIPHERAL STENT (LENGTH 100MM, DIAMETER 6MM) WAS SUCCESSFULLY IMPLANTED TO THE MID LEFT SFA. THE TARGET LESION EXHIBITED 100% STENOSIS PRE-PROCEDURE AND WAS PREDILATED WITH A 4.0 X 80MM BALLOON. LESS THAN 30% STENOSIS REMAINED POST PROCEDURE. APPROXIMATELY 6.5 MONTHS POST INDEX PROCEDURE, A TARGET VESSEL REVASCULARIZATION WAS PERFORMED TO THE LEFT SFA DUE TO HIGH GRADE STENOSIS OF THE SFA LEFT PROXIMAL AND OCCLUSION OF SFA DISTAL. INVESTIGATOR REPORTED A PROBABLE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY STENT. PATIENT RECOVERED AFTER TREATMENT. COMPLETE SE IS NOT APPROVED FOR USE IN THE US FOR SFA INDICATION BUT IS SIMILAR TO COMPLETE SE WHICH IS APPROVED FOR BILIARY/ ILIAC INDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE PERIPHERAL STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR NA V00167567

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention PATIENT WAS TAKING ASPIRIN AT TIME OF EVENT