BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WELLFLEX BILIARY RX STENT SYSTEM

    MDR report key: 2103493 · Received May 26, 2011

    Report

    Report Number
    3005099803-2011-01801
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS DETERMINED THAT NO ISSUES WERE NOTED WITH THE RETURNED DEVICE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE STENT DELIVERY SYSTEM WAS RETURNED TOGETHER WITH A FULLY MOUNTED UNDEPLOYED STENT. INITIAL EXAMINATION OF THE DEVICE FOUND NO ISSUES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. AN ATTEMPT WAS MADE TO DEPLOY THE STENT AND IT DEPLOYED FREELY ON THE FIRST ATTEMPT WITH NO RESTRICTIONS NOTED. NO FURTHER ISSUES WERE NOTED WITH THE RETURNED DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS OF STENT PARTIALLY DEPLOYED REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED DURING A BILIARY STENTING PROCEDURE WITHIN THE SPHINCTER OF ODDI ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A 4.5CM MALIGNANT TUMOR IN THE COMMON BILE DUCT. THE ANATOMY WAS VERY TORTUOUS; HOWEVER NO DILATATION WAS PERFORMED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE THE PHYSICIAN WAS ONLY ABLE TO DEPLOY APPROXIMATELY 2CM OF THE STENT. THE PARTIALLY DEPLOYED STENT WAS UNABLE TO BE RECONSTRAINED; THEREFORE IT WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE "STABILIZED".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED DURING A BILIARY STENTING PROCEDURE WITHIN THE SPHINCTER OF ODDI ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A 4.5CM MALIGNANT TUMOR IN THE COMMON BILE DUCT. THE ANATOMY WAS VERY TORTUOUS; HOWEVER NO DILATATION WAS PERFORMED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE THE PHYSICIAN WAS ONLY ABLE TO DEPLOY APPROXIMATELY 2CM OF THE STENT. THE PARTIALLY DEPLOYED STENT WAS UNABLE TO BE RECONSTRAINED; THEREFORE IT WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE 'STABILIZED'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WELLFLEX BILIARY RX STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570650 13782051

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR