BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM

    MDR report key: 20071413 · Received August 26, 2024

    Report

    Report Number
    3005099803-2024-04103
    Event Type
    Death
    Date Received
    August 26, 2024
    Date of Event
    August 5, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    UDI-DI
    08714729951179
    PMA / PMN Number
    K233318
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF HYPOTENSION. IMDRF PATIENT CODE E050303 CAPTURES THE REPORTABLE EVENT OF PULMONARY EMBOLISM. IMDRF PATIENT CODE E2311 CAPTURES THE REPORTABLE EVENT OF DISCOMFORT. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF CRE DILATION POST STENT PLACEMENT. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF CT SCAN SHOWED NO SIGN OF PERFORATION. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF PATIENT WAS LATER ADMITTED TO ICU. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT PASSED AWAY.

    Additional Manufacturer Narrative · 0

    NOTE: BLOCKS B5 AND H6 (PATIENT CODES) HAVE BEEN UPDATED FOLLOWING A MEDICAL REVIEW CONFIRMING THAT THE AUTOPSY SHOWED A LARGE HEMOPERITONEUM NOT AN EMBOLISM. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK H6: IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E2321 CAPTURES THE REPORTABLE EVENT OF HYPOTENSION. IMDRF PATIENT CODE E2311 CAPTURES THE REPORTABLE EVENT OF DISCOMFORT. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE HEMOPERITONEUM. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF CRE DILATION POST STENT PLACEMENT. IMDRF IMPACT CODE F2203 CAPTURES THE REPORTABLE EVENT OF CT SCAN SHOWED NO SIGN OF PERFORATION. IMDRF IMPACT CODE F0801 CAPTURES THE REPORTABLE EVENT OF PATIENT WAS LATER ADMITTED TO ICU. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF PATIENT PASSED AWAY. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY.

    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 DURING AN ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY (EUS-GJ) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, INITIAL PUNCTURE WAS NOT SUCCESSFUL. HOWEVER, THE PHYSICIAN DID NOT SEE CATHETER IN THE JEJUNAL LUMEN SO THE DEVICE WAS PULLED BACK INTO THE SCOPE, AND RE-PUNCTURED IN A DIFFERENT LOCATION WITH SUCCESSFUL PLACEMENT. POST STENT PLACEMENT, PATIENT EXPERIENCED ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND SHOWED NO SIGNS OF PERFORATION OR AIR IN THE ABDOMEN. PATIENT WAS LATER ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR HYPOTENSION, AND THE PATIENT PASSED AWAY. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF DEATH WAS PULMONARY EMBOLISM.

    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 DURING AN ENDOSCOPIC ULTRASOUND-GUIDED GASTROJEJUNOSTOMY (EUS-GJ) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, INITIAL PUNCTURE WAS NOT SUCCESSFUL. HOWEVER, THE PHYSICIAN DID NOT SEE CATHETER IN THE JEJUNAL LUMEN SO THE DEVICE WAS PULLED BACK INTO THE SCOPE, AND RE-PUNCTURED IN A DIFFERENT LOCATION WITH SUCCESSFUL PLACEMENT. POST STENT PLACEMENT, PATIENT EXPERIENCED ABDOMINAL PAIN. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, AND SHOWED NO SIGNS OF PERFORATION OR AIR IN THE ABDOMEN. PATIENT WAS LATER ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR HYPOTENSION., AND THE PATIENT PASSED AWAY. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF DEATH WAS PULMONARY EMBOLISM. ADDITIONAL INFORMATION ON SEPTEMBER 17, 2024. IT WAS REPORTED THAT THE AUTOPSY OF THE PATIENT SHOWED A LARGE HEMOPERITONEUM. AS PER DR. (B)(6), THIS IS CONSISTENT WITH HIGH LIKELIHOOD OF INTRAPERITONEAL BLEEDING RELATED TO THE PROCEDURE THAT LED TO PATIENTS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941644 AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION M00553660 08714729951179

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Unknown Required Intervention| D