BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX BILIARY RX FULLY COVERED STENT

    MDR report key: 1549640 · Received November 12, 2009

    Report

    Report Number
    3005099803-2009-05368
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Date of Event
    October 14, 2009
    Report Date
    October 14, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (PARTIAL DEPLOYMENT). ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WITH STENT PLACEMENT PERFORMED ON (B)(6) 2009 (60+ YEAR OLD). ACCORDING TO THE COMPLAINANT, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT IN THE COMMON BILE DUCT OF THE PATIENT, BUT THE STENT WOULD NOT DEPLOY. THE PATIENT'S ANATOMY WAS NOT VERY TORTUROUS. THE PHYSICIAN REMOVED THE STENT OUT OF THE SCOPE AND EXAMINED IT. OUTSIDE OF THE PATIENT, THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT AND THEN RECONSTRAIN IT. THE STENT WAS THEN RE-INSERTED BACK INTO THE SCOPE AND INTO THE PATIENT. THE PHYSICIAN WAS THEN ABLE TO DEPLOY THE STENT, BUT ONLY PARTIALLY, AND NOT PAST THE POINT OF NO RETURN MARKER. THE PHYSICIAN WAS NOT ABLE TO FULLY DEPLOY OR RECONSTRAIN THE STENT. THE PHYSICIAN REMOVED THE PARTIALLY DEPLOYED STENT THROUGH THE SCOPE. THE SCOPE REMAINED INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A SHORTER WALLFLEX BILIARY STENT. THERE WERE NO PATIENT COMPLICATIONS OR OTHER INTERVENTION NECESSARY AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX BILIARY RX FULLY COVERED STENT FGE BOSTON SCIENTIFIC CORPORATION M00570540 12640518

    Patients

    Seq Age Sex Outcome Treatment
    1