BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 11628242 · Received April 7, 2021

    Report

    Report Number
    3005099803-2021-01422
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 16, 2021
    Report Date
    May 5, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729951179
    PMA / PMN Number
    K163272
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: MEDICAL DEVICE PROBLEM CODE A150101 CAPTURES THE REPORTABLE EVENT OF STENT FIRST FLANGE FAILED TO EXPAND IN THE STOMACH. MEDICAL DEVICE PROBLEM CODE A1500103 CAPTURES THE REPORTABLE EVENT OF STENT PREMATURELY DEPLOYED. MEDICAL DEVICE PROBLEM CODE A0501 CAPTURES THE REPORTABLE EVENT OF INNER SHEATH DETACHED. BLOCK H10: A HOT AXIOS STENT AND DELIVERY SYSTEM WERE RETURNED FOR ANALYSIS. THE STENT WAS RECEIVED COMPLETELY DEPLOYED. THE DELIVERY SYSTEM WAS RETURNED IN POSITION 4. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE INNER SHEATH DETACHED FROM THE OUTER SHEATH AND THE COPPER WIRE WAS KINKED. A DESTRUCTIVE INSPECTION WAS COMPLETED TO IDENTIFY SUSPECTED TORSION IN THE OUTER SHEATH; HOWEVER, THE DEVICE DID NOT SHOW ANY EVIDENCE OF ROTATIONAL DAMAGE. NO OTHER ISSUES WITH THE STENT AND DELIVERY SYSTEM WERE NOTED. THE REPORTED EVENTS OF STENT PREMATURE DEPLOYMENT, STENT FIRST FLANGE FAILURE TO EXPAND, AND DEVICE ENTRAPMENT OF DEVICE COULD NOT BE CONFIRMED; THE STENT WAS RETURNED COMPLETELY DEPLOYED AND THESE FAILURES OCCURRED DURING THE PROCEDURE AND IT IS NOT POSSIBLE TO REPLICATE IN THE LABORATORY OF ANALYSIS. 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. IT WAS REPORTED THAT THE AXIOS STENT WAS IMPLANTED TRANSGASTRIC TO THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE. HOWEVER, THE IFU STATES, "THE HOT 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 WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL". FURTHERMORE, IT WAS ALSO REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. HOWEVER THE IFU STATES, "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE." ACCORDING TO THE EVIDENCE FOUND IN THE PRODUCT ANALYSIS, THE OUTER SHEATH HAS NO EVIDENCE OF TORSION; THEREFORE, THE REPORTED EVENT OF THE HANDLE BEING INCORRECTLY ROTATED CANNOT BE CONFIRMED. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT AND THE OBSERVED FAILURES WERE LIKELY DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE. IT MAY BE THAT THE USE OF THE DEVICE IN THE INCORRECT ANATOMICAL LOCATION COULD HAVE CAUSED THE FIRST FLANGE FAILURE TO EXPAND AND DEVICE ENTRAPMENT, WHICH COULD HAVE CAUSED THE PHYSICIAN TO FEEL RESISTANCE, LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE DETACHMENT OF THE INNER SHEATH AND THE KINKS IN THE COPPER WIRE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS CAUSE TRACED TO INTENTIONAL OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE REVEALED THAT NO ANOMALIES OR DEVIATIONS RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSGASTRIC TO THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE PERFORMED ON (B)(6), 2021. DURING THE PROCEDURE, THE FIRST FLANGE WAS DEPLOYED; HOWEVER, THE FIRST FLANGE DID NOT FULLY EXPAND AND IT APPEARED THE TIP OF THE STENT WAS CAUGHT ON THE TIP OF THE CATHETER. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE SECOND FLANGE; HOWEVER, THE SECOND FLANGE FAILED TO DEPLOY. REPORTEDLY, DURING REMOVAL, THE STENT FULLY DEPLOYED IN THE SCOPE AND WAS REMOVED FROM THE SCOPE WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER AXIOS STENT. THE DELIVERY SYSTEM WAS EXAMINED AND THE INNER SHEATH WAS DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. A PHOTO OF THE DEVICE PROVIDED BY THE COMPLAINANT SHOWS THAT THE INNER SHEATH WAS DETACHED. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TRANSGASTRIC TO THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE. HOWEVER, PER THE HOT 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 WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE PLACED TRANSGASTRIC TO THE STOMACH. IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. THE HOT AXIOS STENT AND DELIVERY SYSTEM DIRECTIONS FOR USE STATE, "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE."

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 ON (B)(6) 2021 THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSGASTRIC TO THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) (EDGE) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE FIRST FLANGE WAS DEPLOYED; HOWEVER, THE FIRST FLANGE DID NOT FULLY EXPAND AND IT APPEARED THE TIP OF THE STENT WAS CAUGHT ON THE TIP OF THE CATHETER. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE SECOND FLANGE; HOWEVER, THE SECOND FLANGE FAILED TO DEPLOY. REPORTEDLY, DURING REMOVAL, THE STENT FULLY DEPLOYED IN THE SCOPE AND WAS REMOVED FROM THE SCOPE WITH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER AXIOS STENT. THE DELIVERY SYSTEM WAS EXAMINED AND THE INNER SHEATH WAS DETACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. A PHOTO OF THE DEVICE PROVIDED BY THE COMPLAINANT SHOWS THAT THE INNER SHEATH WAS DETACHED. NOTE: IT WAS REPORTED THAT THE AXIOS STENT WAS PLACED TRANSGASTRIC TO THE STOMACH DURING AN ENDOSCOPIC ULTRASOUND (EUS) DIRECTED TRANSGASTRIC ERCP (EDGE) PROCEDURE. HOWEVER, PER THE HOT 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 WITH >= 70% FLUID CONTENT THAT ARE ADHERENT TO THE GASTRIC OR BOWEL WALL. THE DEVICE IS NOT INDICATED TO BE PLACED TRANSGASTRIC TO THE STOMACH. IT WAS REPORTED THAT THE HANDLE WAS ROTATED AS THE DEVICE WAS LUER LOCKED TO THE SCOPE. THE HOT AXIOS STENT AND DELIVERY SYSTEM DIRECTIONS FOR USE STATE, "ROTATE THE WINGED LUER LOCK CLOCKWISE TO SECURE THE DELIVERY SYSTEM HANDLE TO THE ECHOENDOSCOPE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523266 AXIOS PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553660 0026791214 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention