BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

    MDR report key: 1890361 · Received November 3, 2010

    Report

    Report Number
    2134265-2010-04920
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL STENTING TREATMENT PROCEDURE, THE STENT MOVED ON THE BALLOON. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS LEFT EXTERNAL ILIAC ARTERY (EIA). THE ECCENTRICALLY SHAPED LESION WAS 20MM IN LENGTH AND 7MM IN DIAMETER. A NON BSC GUIDE WIRE AND A 25CM 7FR SUPER SHEATH WERE PLACED IN THE PATIENT. THE LESION WAS PRE-DILATED WITH A SYNERGY BALLOON CATHETER. THE PHYSICIAN NOTED RESISTANCE WHILE ADVANCING THE 7.0X30X75CM EXPRESS LD ILIAC/BILIARY STENT SYSTEM TO THE LESION. THE STENT WAS ADVANCED 30-40MM FURTHER THAN THE INTENDED LOCATION AND WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE STENT, ITS EDGE CAUGHT ON THE SUPER SHEATH IN A SHARP BEND IN THE VESSEL. THE STENT WAS MOVED PARTIALLY OFF THE BALLOON OF THE DELIVERY DEVICE. THE PHYSICIAN ADVANCED THE STENT APPROXIMATELY 5-10MM DISTAL TO REACH THE LESION. ONLY THE PROXIMAL PORTION OF THE STENT WAS DEPLOYED AS THE STENT HAD SHIFTED TO THE DISTAL PORTION OF THE BALLOON. THE WIRE WAS EXCHANGED FOR A 0.014" NON BSC WIRE AND POST-DILATATION OF THE DISTAL PORTION OF THE STENT WAS PERFORMED WITH A 7X20 STERLING BALLOON CATHETER. THE STENT WAS WELL POSITIONED AND WELL APPOSED AT PROCEDURE END. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938046730750 0012981036

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 25CM 7FR SUPER SHEATH| SYNERGY BALLOON CATHETER