BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS

    MDR report key: 20953419 · Received December 17, 2024

    Report

    Report Number
    3005099803-2024-06368
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    September 18, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNS
    PMA / PMN Number
    K233318
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B2B: ADDITIONAL PRO CODE: PCU; REPORTED HERE AS THE PRO CODE EXCEEDED CHARACTER LIMIT FOR DESIGNATED FIELD. BLOCK H6: IMDRF PATIENT CODE E1032 CAPTURES THE REPORTABLE EVENT OF VOMITING. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF PATIENT CODE E1025 CAPTURES THE REPORTABLE EVENT OF REFLUX ESOPHAGITIS. IMDRF IMPACT CODE F08 CAPTURES THE PATIENT'S HOSPITAL ADMISSION FOR TREATMENT AND EVALUATION. IMDRF IMPACT CODE F2202 CAPTURES THE ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED. IMDRF IMPACT CODE F2203 CAPTURES THE COMPUTED TOMOGRAPHY (CT) SCAN TO CHECK THE STENT. IMDRF IMPACT CODE F2303 CAPTURES THE MEDICATIONS PROVIDED TO ADDRESS THE VOMITING AND REFLUX ESOPHAGITIS. IMDRF DEVICE CODE A0106 CAPTURES THE REPORTABLE EVENT OF STENT OBSTRUCTION WITHIN DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT AND ELECTROCAUTERY-ENHANCED DELIVERY SYSTEM WAS IMPLANTED TRANSGASTRIC TO THE JEJUNUM TO TREAT A GASTRIC OUTLET OBSTRUCTION PERFORMED ON (B)(6) 2024, AS PART OF THE E7127 AXIOS PASSAGE CLINICAL STUDY. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN DEPLOYING THE STENT'S FIRST FLANGE. EVENTUALLY, THE STENT WAS DEPLOYED BY RATTLING THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE AND THERE WERE NO PATIENT COMPLICATIONS NOTED. ON (B)(6) 2024, 23 DAYS POST-STENT PLACEMENT, THE PATIENT WAS NOTED WITH CHOLANGITIS AND WAS ADMITTED ON THE SAME DAY FOR FURTHER EVALUATION. THE PATIENT WAS GIVEN MEDICATION, THE STENT WAS EXCHANGED WITH AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD), AND PLASTIC STENT WAS PLACED. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2024, 59 DAYS POST-STENT PLACEMENT, THE PATIENT WAS NOTED WITH VOMITING. THE FOLLOWING DAY, ON (B)(6) 2024, VOMITING PERSISTED AND STENT MALFUNCTION WAS SUSPECTED. SUBSEQUENTLY, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT; AND WAS GIVEN MEDICATIONS TO TREAT VOMITING. COMPUTED TOMOGRAPHY (CT) SCAN REVEALED FOOD BOLUS IMPACTION AT THE AXIOS STENT BETWEEN THE STOMACH AND JEJUNUM. THE PRESSURE OF THE GASTRIC TUBE WAS THEN REDUCED, AND THE SYMPTOMS IMPROVED WITH GASTRIC TUBE MANAGEMENT. SUBSEQUENTLY, ONE CT SCAN REVEALED SUSPECTED MULTIPLE METASTASES TO THE LIVER AND MILD RIGHT PNEUMONIA, AND THEN A REINTERVENTION WITH A STOMACH TUBE AND ANOTHER CT SCAN WAS MADE TO TREAT THE STENT OBSTRUCTION. HOWEVER, ON (B)(6) 2024, AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED UNDER FLUOROSCOPY, BUT NO CLEAR OBSTRUCTION WAS OBSERVED, SO THE PATIENT'S DIET WAS MODIFIED. ON THE SAME DAY, THE PATIENT WAS NOTED WITH REFLUX ESOPHAGITIS AND WAS RECOMMENDED WITH MEDICATIONS OF PROTON PUMP INHIBITORS (PPI) AND THE PATIENT WAS NOTED WITH TRANSIENT PYREXIA AT NIGHT. BOTH EVENTS WERE RESOLVED ON THE UPCOMING DAYS. ON (B)(6) 2024, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. NOTE: IT WAS REPORTED THAT "THE STENT WAS EXCHANGED WITH AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD), AND PLASTIC STENT WAS PLACED ON (B)(6) 2024." HOWEVER, THE STUDY ALLEGATIONS ALSO INDICATE THAT THE AXIOS STENT REMAINED IMPLANTED. SEVERAL GOOD FAITH EFFORTS WERE SENT BUT WE WERE UNABLE TO CONFIRM IF THE AXIOS STENT WAS EXPLANTED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289257 AXIOS UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS BOSTON SCIENTIFIC CORPORATION M00553660 0033338662

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Hospitalization| R