BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6043393 · Received October 20, 2016

    Report

    Report Number
    3005099803-2016-03211
    Event Type
    Injury
    Date Received
    October 20, 2016
    Report Date
    September 26, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: BANG, ET AL. "LUMEN-APPOSING METAL STENTS (LAMS) FOR PANCREATIC FLUID COLLECTION (PFC) DRAINAGE: MAY NOT BE BUSINESS AS USUAL." GUT 2016; 0: 1-3. DOI HTTP://DX.DOI.ORG/10.1136/GUTJNL-2016-312812. 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. 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 MANUFACTURER 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 THIS REPORT: #3005099803-2016-03211). ONE PATIENT PRESENTED WITH OBSTRUCTIVE JAUNDICE AT 5 WEEKS POST-STENT PLACEMENT. AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED AND IT WAS NOTED THAT THE PATIENT HAD A BILIARY STRICTURE AT THE COMMON BILE DUCT SECONDARY TO MECHANICAL COMPRESSION BY THE STENT, WHICH HAD BEEN DEPLOYED VIA THE DUODENAL BULB. THE STENT WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS SUCCESSFULLY TREATED BY PLACING A 10 FR PLASTIC BILIARY STENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 20, 2016: ACCORDING TO THE CORRESPONDING AUTHOR OF THE ARTICLE, THE EVENT OF DIFFICULTY REMOVING THE STENT WITH RESULTANT BLEEDING DESCRIBED IN THE ARTICLE DID NOT OCCUR IN THE SAME PATIENT AS THE EVENT OF SPLENIC ARTERY EROSION AND BLEEDING INITIALLY CAPTURED IN MANUFACTURER REPORT #3005099803-2016-01269. THEREFORE, THE EVENT OF DIFFICULTY REMOVING THE STENT WITH BLEEDING AS DESCRIBED IN THE ARTICLE WILL ALSO BE CAPTURED IN THIS REPORT: #3005099803-2016-03211. ACCORDING TO THE LITERATURE, WHEN THE 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; HOWEVER, THIS PRECIPITATED HEMORRHAGE REQUIRING IR-GUIDED COIL EMBOLIZATION.

    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. 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 MANUFACTURER 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 THIS REPORT: #3005099803-2016-03211). ONE PATIENT PRESENTED WITH OBSTRUCTIVE JAUNDICE AT 5 WEEKS POST-STENT PLACEMENT. AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE WAS PERFORMED AND IT WAS NOTED THAT THE PATIENT HAD A BILIARY STRICTURE AT THE COMMON BILE DUCT SECONDARY TO MECHANICAL COMPRESSION BY THE STENT, WHICH HAD BEEN DEPLOYED VIA THE DUODENAL BULB. THE STENT WAS REMOVED FROM THE PATIENT AND THE PATIENT WAS SUCCESSFULLY TREATED BY PLACING A 10 FR PLASTIC BILIARY STENT. 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
    694644 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - MARLBOROUGH M00553650

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention