BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS

    MDR report key: 20798569 · Received November 27, 2024

    Report

    Report Number
    3005099803-2024-06058
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 31, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    UDI-DI
    08714729951179
    PMA / PMN Number
    K163272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE: KNS, PCU; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K) #: K163272, K181905, K220112, K233318; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED. BLOCK H11: AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT PARTIALLY DEPLOYED AND THE OUTER SHEATH DETACHED FROM THE DEPLOYMENT HUB. NO OTHER PROBLEMS WERE NOTED TO THE STENT AND DELIVERY SYSTEM. THE REPORTED EVENT OF STENT PARTIALLY DEPLOYED CAN BE CONFIRMED. THE ADDITIONAL OBSERVED DAMAGE OF OUTER SHEATH DETACHED WAS LIKELY DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE. IT MAY BE THAT LESION CHARACTERISTICS, HANDLING OF THE DEVICE AND THE TECHNIQUE USED BY THE PHYSICIAN (FORCE APPLIED), LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE OBSERVED DAMAGE. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE IFU (INSTRUCTIONS FOR USE) / PRODUCT LABEL. THE COMPLAINANT REPORTED THAT THE DEVICE WAS INTENDED TO BE PLACED TO TREAT AN ENTERAL OBSTRUCTION. THE IFU STATES, "THE AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM INSTRUCTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED FOR PLACEMENT FOR THE TREATMENT OF ENTERAL OBSTRUCTION. ADDITIONALLY, STENT PARTIALLY DEPLOYED IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE DEVICE IN THE MANUFACTURER'S LABELING. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE ROOT CAUSE IS KNOWN INHERENT RISK OF DEVICE.

    Additional Manufacturer Narrative · 0

    BLOCK D2B: PRODUCT CODE: KNS, PCU; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G4: PREMARKET / 510(K) #: K163272, K181905, K220112, K233318; REPORTED HERE AS THE PRODUCT CODE EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE SMALL BOWEL TO TREAT AN ENTERAL OBSTRUCTION DURING A LUMEN-APPOSING METAL STENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, BUT THE DISTAL FLANGE WOULD NOT DEPLOY. THE PHYSICIAN ATTEMPTED TO PUSH ANOTHER WIRE THROUGH THE CATHETER, BUT IT WOULD STILL NOT WORK. SUBSEQUENTLY, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT AN ENTERAL OBSTRUCTION. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED FOR PLACEMENT FOR THE TREATMENT OF ENTERAL OBSTRUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS TO BE IMPLANTED IN THE SMALL BOWEL TO TREAT AN ENTERAL OBSTRUCTION DURING A LUMEN-APPOSING METAL STENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT, BUT THE DISTAL FLANGE WOULD NOT DEPLOY. THE PHYSICIAN ATTEMPTED TO PUSH ANOTHER WIRE THROUGH THE CATHETER, BUT IT WOULD STILL NOT WORK. SUBSEQUENTLY, THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED AND ANOTHER AXIOS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS INTENDED TO BE PLACED TO TREAT AN ENTERAL OBSTRUCTION. HOWEVER, PER THE AXIOS STENT AND ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE TO FACILITATE TRANSGASTRIC OR TRANSDUODENAL ENDOSCOPIC DRAINAGE OF SYMPTOMATIC PANCREATIC PSEUDOCYSTS >= 6 CM IN SIZE AND WALLED-OFF NECROSIS >= 6 CM IN SIZE THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED FOR PLACEMENT FOR THE TREATMENT OF ENTERAL OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826930 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553660 0033998885 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown