BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6043396 · Received October 20, 2016

    Report

    Report Number
    3005099803-2016-03249
    Event Type
    Malfunction
    Date Received
    October 20, 2016
    Report Date
    October 12, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC UPN AND LOT WERE NOT REPORTED; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. REPORTED EVENT OF STENT DIFFICULT TO REMOVE. (B)(4). THE DEVICES HAVE NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE, FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THROUGH THE ARTICLE "LUMEN-APPOSING METAL STENTS (LAMS) FOR PANCREATIC FLUID COLLECTION (PFC) DRAINAGE: MAY NOT BE BUSINESS AS USUAL" WRITTEN BY JI YOUNG BANG, ET AL. (SEE ATTACHED ARTICLE). ACCORDING TO THE LITERATURE, HOT AXIOS STENTS WERE IMPLANTED IN 12 PATIENTS TO TREAT SYMPTOMATIC WALLED-OFF NECROSIS (WON) MEASURING GREATER THAN 6 CM IN SIZE AND LOCATED ADJACENT TO THE GASTRIC OR DUODENAL LUMEN. A FOLLOW-UP CT WAS OBTAINED AT 4-6 WEEKS POST-STENT PLACEMENT TO ASSESS TREATMENT RESPONSE. STENT-RELATED ADVERSE EVENT WERE OBSERVED IN 6 PATIENTS. THESE ADVERSE EVENTS INCLUDED 3 CASES OF DELAYED BLEEDING AFTER HOSPITAL DISCHARGE (CAPTURED IN MANUFACTURER REPORTS #3005099803-2016-01268, #3005099803-2016-01270, AND #3005099803-2016-01765), 1 CASE OF DIFFICULTY REMOVING THE STENT WITH NO PATIENT COMPLICATIONS (CAPTURED IN THIS REPORT: #3005099803-2016-03249), 1 CASE OF DIFFICULTY REMOVING THE STENT WITH RESULTANT BLEEDING (CAPTURED IN MANUFACTURER REPORT #3005099803-2016-01269), AND 1 CASE OF DISTAL BILIARY STRICTURE (CAPTURED IN MANUFACTURER REPORT #3005099803-2016-03211). WHEN ONE PATIENT PRESENTED FOR ROUTINE OUTPATIENT ENDOSCOPIC STENT REMOVAL, THE STENT WAS FOUND TO BE BURIED UNDER GASTRIC MUCOSA ON FLUOROSCOPY. REMOVAL OF THE STENT WAS TECHNICALLY CHALLENGING. AFTER PASSAGE OF A GUIDEWIRE VIA AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE TRANSMURAL TRACT WAS DILATED TO 12 MM USING A RADIAL EXPANSION BALLOON. ATTEMPTS TO REMOVE THE STENT ENDOSCOPICALLY USING RAT-TOOTH FORCEPS AND A 15MM STONE EXTRACTION BALLOON WERE UNSUCCESSFUL. THE STENT WAS SUCCESSFULLY RETRIEVED WITH LARGE 8 MM BIOPSY FORCEPS. BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696186 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - MARLBOROUGH M00553650

    Patients

    Seq Age Sex Outcome Treatment
    1