BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ SCHATZ STENT LONG MED 78MMX8

    MDR report key: 823092 · Received February 26, 2007

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    Report

    Report Number
    9610978-2007-00110
    Event Type
    Injury
    Date Received
    February 26, 2007
    Date of Event
    February 3, 2007
    Report Date
    February 8, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO CORDIS FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS (R0305214) MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7121887 WITH LOT NUMBER 0503050057. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING THE STENT RETENTION TEST VALUES. WITHOUT RETURN OF THE PRODUCT, THE COMPLAINT CANNOT BE CONFIRMED AND IT CANNOT BE DETERMINED IF THE STENT WAS PROPERLY CRIMPED ON THE BALLOON. IN THIS CASE, LESION/VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS LIKELY CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT WAS MISALIGNED ON THE BALLOON AND THE TIP OF THE STENT FRAYED. THE INTENDED PROCEDURE WAS STENTING OF A LESION IN THE LEFT EXTERNAL ILIAC ARTERY. THE VESSEL HAD SEVERE CALCIFICATION, SEVERE TORTUOSITY AND 100% STENOSIS. THE LESION WAS PRE-DILATED. NO ANOMALIES WERE NOTED DURING INSPECTION OF THE STENT DELIVERY SYSTEM (SDS) PRIOR TO USE. THE PRODUCT WAS PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). RESISTANCE WAS EXPERIENCED, AS THE SDS WAS ADVANCED TO THE LESION AND IT WAS NOTED THAT THE STENT BECAME MISALIGNED. THE SDS WAS WITHDRAWN AT WHICH TIME IT WAS NOTED THAT THE TIP OF THE STENT WAS FRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ SCHATZ STENT LONG MED 78MMX8 ENDOVASCULAR SDS/STENTS(FGE) FGE CORDIS EUROPA, N.V. NA R0305214

    Patients

    Seq Age Sex Outcome Treatment
    1 * SHEATH INTRODUCER.| TERUMO RADIFOCUS GUIDEWIRE 0.035INCH X 150CM,