BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS SD BILIARY STENT SYSTEM

    MDR report key: 2050690 · Received April 12, 2011

    Report

    Report Number
    2134265-2011-01229
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 RENAL TREATMENT PROCEDURE REMOVAL DIFFICULTY AND STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT RADIAL ARTERY. THE 90% INSTENT RESTENOSED DENOVO LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED RIGHT RENAL ARTERY THE LESION WAS PRE DILATED WITH A 3X20 STERLING ES BALLOON CATHETER. WHILE ADVANCING A 6.0X18X150CM EXPRESS SD STENT DELIVERY SYSTEM DIFFICULTY WAS ENCOUNTERED CROSSING THE HEAVILY CALCIFIED VESSEL. DURING THE ATTEMPT TO WITHDRAW THE STENT DELIVERY SYSTEM THE DEVICE WOULD NOT PULL BACK INTO THE GUIDE CATHETER. AS A RESULT THE GUIDE CATHETER AND EXPRESS SD SYSTEM WERE REMOVED TOGETHER AS ONE UNIT. HOWEVER, DURING WITHDRAW THE STENT BECAME CAUGHT ON THE GUIDE SHEATH AND DETACHED IN THE BRACHIAL ARTERY. A 4X2 STERLING BALLOON CATHETER WAS ADVANCED TO DEPLOY THE DISLODGED STENT. THE BALLOON WAS INFLATED TO 14ATMS AND THE STENT WAS WELL POSITIONED AND FULLY APPOSED IN THE BRACHIAL ARTERY. THE PROCEDURE WAS COMPLETED WITH SUCCESSFUL PLACEMENT OF A 5X19 RENAL SD STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS DISCHARGED WITHIN 24 HOURS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS SD BILIARY STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937912618150 13402982

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention BALLOON CATHETER, 3X20 STERLING ES| GUIDE CATHETER, JR4 CORDIS CORONARY| GUIDE WIRE, 014 JOURNEY| INTRODUCER SHEATH, 6F RENAL GUIDE SHEATH