BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057

    MDR report key: 1913910 · Received December 3, 2010

    Report

    Report Number
    3005099803-2010-05025
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PARTIALLY DEPLOYED BY 10 MM. THE CATHETER WAS KINKED AT THE GUIDEWIRE ACCESS PORT. THE OUTER SHEATH WAS ACCORDIONED AT THE PROXIMAL END OF THE MOUNTED STENT. DURING ANALYSIS, DESPITE SEVERAL ATTEMPTS, IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH BY HAND OR TO RECONSTRAIN THE STENT. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT OR THE INNER LUMEN. 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 REPORTED FOR THIS LOT. A LABELING REVIEW IDENTIFIED THAT THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE DFU / PRODUCT LABEL STATES "THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS. THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM IS CONTRAINDICATED FOR PLACEMENT IN BILIARY STRICTURES CAUSED BY BENIGN TUMORS, AS THE LONG-TERM EFFECTS OF THE STENT IN THE BILE DUCT IS UNKNOWN." HOWEVER, THE COMPLAINT STATES THAT THE DEVICE WAS USED TO TREAT A NON MALIGNANT STENOSIS AS A RESULT OF CHRONIC PANCREATITIS THAT NEEDED TO BE DILATED. THE MOST PROBABLE ROOT CAUSE IS USE/USER ERROR.

    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 COVERED STENT WAS USED WITHIN THE COMMON BILE DUCT OF A PATIENT WITH CHRONIC PANCREATITIS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A NON MALIGNANT STENOSIS THAT NEEDED TO BE DILATED. THE ANATOMY WAS NOT TORTUOUS. IT WAS REPORTED THAT THE PATIENT'S ANATOMY WAS PREVIOUSLY DILATED WITH FOUR PLASTIC STENTS THAT OCCLUDED, WERE REMOVED AND REPLACED. FOUR WEEKS LATER THE PLASTIC STENTS OCCLUDED AGAIN. DURING THE PROCEDURE ON (B)(6), 2010, DEPLOYMENT WAS STARTED; HOWEVER THE STENT WAS NOT POSITIONED CORRECTLY, SO STENT RECONSTRAINMENT WAS ATTEMPTED. THE PHYSICIAN FELT A "SNAP", AND IT WAS NOT POSSIBLE TO FULLY RECONSTRAIN OR DEPLOY THE STENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A10 X 60MM WALLFLEX BILIARY RX COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE "GOOD-STABLE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX COVERED STENT WAS USED WITHIN THE COMMON BILE DUCT OF A PATIENT WITH CHRONIC PANCREATITIS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A NON MALIGNANT STENOSIS THAT NEEDED TO BE DILATED. THE ANATOMY WAS NOT TORTUOUS. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY WAS PREVIOUSLY DILATED WITH FOUR PLASTIC STENTS THAT OCCLUDED, WERE REMOVED AND REPLACED. FOUR WEEKS LATER THE PLASTIC STENTS OCCLUDED AGAIN. DURING THE PROCEDURE ON (B)(6), 2010, DEPLOYMENT WAS STARTED; HOWEVER THE STENT WAS NOT POSITIONED CORRECTLY, SO STENT RECONSTRAINMENT WAS ATTEMPTED. THE PHYSICIAN FELT A "SNAP", AND IT WAS NOT POSSIBLE TO FULLY RECONSTRAIN OR DEPLOY THE STENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A10 X 60MM WALLFLEX BILIARY RX COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION POST PROCEDURE WAS REPORTED TO BE "GOOD-STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M0057 CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570540 13439329

    Patients

    Seq Age Sex Outcome Treatment
    1 PLASTIC STENTS