BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS VASCULAR SD

    MDR report key: 2993118 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01385
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 8, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 STENTING TREATMENT PROCEDURE, STENT DISLODGMENT AND EMBOLIZATION OCCURRED. VASCULAR ACCESS WAS OBTAINED WITH A 6F NON BSC SHEATH VIA THE RIGHT FEMORAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE DOWNWARD SLOPING RENAL ARTERY. A NON BSC CATHETER AND A .018 NON BSC GUIDE WIRE WERE PLACED AT THE TARGET LESION. TWO ATTEMPTS WERE MADE TO PASS THE EXPRESS VASCULAR SD SDS THROUGH THE STENOSIS BUT THE DEVICE WAS UNABLE TO ADVANCE. DURING THE ATTEMPT TO ADVANCE, THE EXPRESS VASCULAR SDS WAS SLIGHTLY PUSHING THE GUIDE WIRE AND SHEATH, ALMOST LOSING VASCULAR ACCESS. THE VESSEL WAS REWIRED WITH A V18 GUIDE WIRE FOR EXTRA SUPPORT. THE EXPRESS VASCULAR SDS WAS READVANCED AND WIRE ACCESS WAS LOST. THE EXPRESS VASCULAR SDS AND THE V18 GUIDE WIRE WERE PULLED INTO SHEATH AND IT WAS NOTED THAT THE STENT HAD DISLODGED. UNDER FLUOROSCOPY IT WAS NOTED THAT THE STENT WAS A "STANDING" ON TOP OF THE TIP OF THE SHEATH BUT QUICKLY EMBOLIZED TO THE LEFT COMMON ILIAC ARTERY, THEN DOWN TO THE LEFT PROFUNDA DISTAL MAIN TRUNK AND BECAME LODGED. UPSIZED TO A 7F NON BSC SHEATH AND PLACED A BERNSTEIN CATHETER. USING A NON BSC SNARE, WAS ABLE TO RETRIEVE THE STENT INTO THE SHEATH AND REMOVE FROM THE PATIENT WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS LISTED AS FINE. PATIENT TO RETURN IN TWO WEEKS FOR RENAL STENTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97367 EXPRESS VASCULAR SD CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE UNK135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE, FLEXT 018| GUIDE CATHETER, SOF| INTRODUCER SHEATH, 6F ANSEL