BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6947464 · Received October 13, 2017

    Report

    Report Number
    3005099803-2017-03056
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 18, 2017
    Report Date
    September 18, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    PCU
    UDI-DI
    08714729904588
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A HOT AXIOS DELIVERY SYSTEM WAS RECEIVED FOR ANALYSIS; THE STENT WAS NOT RETURNED. A VISUAL EVALUATION NOTED THAT THE POLYMIDE INNER SHAFT OF THE DELIVERY SYSTEM WAS DETACHED, LEAVING THE ELECTROCAUTERY WIRE AT THE DISTAL END OF THE DEVICE EXPOSED. THE DETACHED INNER SHAFT WAS NOT RETURNED. THE CATHETER DIAMETER WAS MEASURED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. DEVICE ANALYSIS DETERMINED THAT THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. THE CAUSE OF THE REPORTED DEPLOYMENT DIFFICULTIES WAS MOST PROBABLY DUE TO ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE CONFIRMED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED AND CONFIRMED THAT THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. IT WAS REPORTED THAT THE STENT WAS BEING IMPLANTED FOR GALLBLADDER DRAINAGE; HOWEVER, THE DFU STATES "HOT AXIOS STENT AND DELIVERY SYSTEM IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS = 6CM IN SIZE AND WALLED-OFF NECROSIS = 6CM IN SIZE WITH = 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL."

    Additional Manufacturer Narrative · 1

    (B)(4). 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSDUODENAL TO THE GALLBLADDER DURING A GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S GALLBLADDER REQUIRED DRAINAGE DUE TO SLUDGE. THE PATIENT WAS NOTED TO BE SICK AND HIGH RISK, AND AXIOS PLACEMENT WAS ATTEMPTED TO AVOID SURGERY. ACCORDING TO THE COMPLAINANT, DURING DEPLOYMENT OF THE STENT, AS THE PHYSICIAN DEPLOYED THE FIRST FLANGE, THE DEPLOYMENT SEEMED STUCK. THE PHYSICIAN THEN TRIED TO REMOVE THE CATHETER FROM THE SCOPE; HOWEVER, THE STENT PREMATURELY DEPLOYED OFF THE CATHETER AND BECAME STUCK IN THE SCOPE CHANNEL. THE STENT REMAINED STUCK IN THE SCOPE CHANNEL WHEN THE SCOPE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN DID NOT HAVE ANOTHER AXIOS DEVICE AVAILABLE AND THE SCOPE WAS DAMAGED. THE PATIENT WAS SENT TO SURGERY TO HAVE HER GALLBLADDER REMOVED. ACCORDING TO THE COMPLAINANT, THE GALLBLADDER REMOVAL WAS NOT A RESULT OF THE ISSUE WITH THE AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. NOTE: THE HOT AXIOS STENT WAS BEING IMPLANTED TRANSDUODENAL TO THE GALLBLADDER; HOWEVER THE HOT AXIOS STENT AND DELIVERY SYSTEM IS NOT INDICATED FOR PLACEMENT IN THE GALLBLADDER IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSDUODENAL TO THE GALLBLADDER DURING A GALLBLADDER DRAINAGE PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S GALLBLADDER REQUIRED DRAINAGE DUE TO SLUDGE. THE PATIENT WAS NOTED TO BE SICK AND HIGH RISK, AND AXIOS PLACEMENT WAS ATTEMPTED TO AVOID SURGERY. ACCORDING TO THE COMPLAINANT, DURING DEPLOYMENT OF THE STENT, AS THE PHYSICIAN DEPLOYED THE FIRST FLANGE, THE DEPLOYMENT SEEMED STUCK. THE PHYSICIAN THEN TRIED TO REMOVE THE CATHETER FROM THE SCOPE; HOWEVER, THE STENT PREMATURELY DEPLOYED OFF THE CATHETER AND BECAME STUCK IN THE SCOPE CHANNEL. THE STENT REMAINED STUCK IN THE SCOPE CHANNEL WHEN THE SCOPE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN DID NOT HAVE ANOTHER AXIOS DEVICE AVAILABLE AND THE SCOPE WAS DAMAGED. THE PATIENT WAS SENT TO SURGERY TO HAVE HER GALLBLADDER REMOVED. ACCORDING TO THE COMPLAINANT, THE GALLBLADDER REMOVAL WAS NOT A RESULT OF THE ISSUE WITH THE AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. NOTE: THE HOT AXIOS STENT WAS BEING IMPLANTED TRANSDUODENAL TO THE GALLBLADDER; HOWEVER THE HOT AXIOS STENT AND DELIVERY SYSTEM IS NOT INDICATED FOR PLACEMENT IN THE GALLBLADDER IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729118 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - GALWAY M00553640 20981185 08714729904588

    Patients

    Seq Age Sex Outcome Treatment
    1