BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX HERCULINK ELITE STENT SYSTEM

    MDR report key: 1867646 · Received October 8, 2010

    Report

    Report Number
    3004742046-2010-00469
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    FGE
    PMA / PMN Number
    K063481
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD COULD NOT BE PERFORMED. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFO. THE HERCULINK ELITE (PART 1011487-12, LOT UNK) IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED INTERVENTIONAL PROCEDURE OF THE RENAL ARTERY, THE 4.0X12 HERCULINK ELITE COULD NOT COMPLETELY CROSS THE TARGET LESION AND DURING REMOVAL THE STENT DISLODGED AND REMAINED IN THE VESSEL PLAQUE. THE DISLODGED STENT WAS RETRIEVED WITH AN UNSPECIFIED SNARE DEVICE. THERE WAS NO REPORTED PT EFFECT. THE VESSEL WAS RE-WIRED AND A 4.0X15 HERCULINK ELITE WAS USED SUCCESSFULLY. IT WAS NOTED BY TWO PHYSICIANS VIEWING THE ANGIOGRAM THAT EITHER A DISSECTION OR A THROMBUS WAS DISTAL TO THE STENT, HOWEVER, WAS CONCLUDED TO BE THROMBUS. THE PT WAS GIVEN HEPARIN AND A THROMBECTOMY WAS ATTEMPTED. THE PT WAS REPORTEDLY IN STABLE CONDITION BUT THE PROCEDURE WAS CONTINUING AS THE PHYSICIANS WERE 'INTERVENING ON THE CLOT'. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX HERCULINK ELITE STENT SYSTEM FGE ABBOTT VASCULAR-VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention (#2) UNSPECIFIED GUIDE WIRE| OTHER: HEPARIN| HERCULINK ELITE (PART 1011487-12, LOT UNK)| GUIDE WIRE: SPARATACORE| UNSPECIFIED SNARE DEVICE