BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX¿ BILIARY

    MDR report key: 3073127 · Received April 23, 2013

    Report

    Report Number
    3005099803-2013-03013
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K061231
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF STENT SIZE INCORRECT FOR PATIENT. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: ACCORDING TO THE PHYSICIAN, IT COULD NOT BE DETERMINED WHICH OF THE TWO STENTS WAS PERCEIVED TO BE THE WRONG SIZE. THEREFORE, THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS FOR THE SAME EVENT. REFER TO MANUFACTURER REPORT #'S 3005099803-2013-03013 AND 3005099803-2013-03014. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO WALLFLEX BILIARY RX UNCOVERED STENTS WERE IMPLANTED NEAR THE HILUM IN THE RIGHT AND LEFT HEPATIC BILE DUCTS OF A PATIENT ON (B)(6) 2013 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR THE STENT PLACEMENTS WAS FOR TREATMENT OF A HILAR STENOSIS. NO DILATATION WAS PERFORMED PRIOR TO THE STENT PLACEMENTS. THE PATIENT'S ANATOMY WAS REPORTED TO NOT BE TORTUOUS. NO VISIBLE ISSUES WERE NOTED TO THE DEVICES. DURING THE PROCEDURE, TWO STENTS WERE SUCCESSFULLY IMPLANTED IN A "Y" BILATERAL PLACEMENT, AT APPROXIMATELY THE SAME DISTANCE FROM THE DUODENUM, WITHIN THE RIGHT AND LEFT HEPATIC BILE DUCTS. HOWEVER, FOLLOWING DEPLOYMENT, THE PHYSICIAN OBSERVED THAT ONE OF THE TWO STENTS APPEARED TO BE THE WRONG SIZE AS IT WAS SHORTER THAN THE OTHER. NO INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. ACCORDING TO THE PHYSICIAN, BOTH STENTS ARE CORRECTLY EXPANDED AND FUNCTIONAL, AS THE PATIENT SHOWS SIGNS OF CLINICAL IMPROVEMENT INCLUDING REGRESSION OF PRURITUS AND JAUNDICE, WITH A DECREASE OF BILIRUBIN RATE. IN ADDITION, THE LESION WAS SUFFICIENTLY COVERED AND DRAINAGE REMAINS ACTIVE "DESPITE THIS ANOMALY". THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE OKAY POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175373 WALLFLEX¿ BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570650 15695639

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR