BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 19734406 · Received July 12, 2024

    Report

    Report Number
    3005099803-2024-03316
    Event Type
    Death
    Date Received
    July 12, 2024
    Date of Event
    March 1, 2018
    Report Date
    July 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE YEAR THE LITERATURE WAS PUBLISHED. BLOCKS D4, H4: THE UPN AND LOT NUMBER OF THE SUSPECT DEVICE WAS NOT PROVIDED IN THE LITERATURE; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK E1: INITIAL REPORTER'S FIRST NAME: (B)(6). BLOCK G2: LITERATURE SOURCE: GARCIA-ALONSO F.J., ET AL. CUMULATIVE RISKS OF STENT MIGRATION AND GASTROINTESTINAL BLEEDING IN PATIENTS WITH LUMEN-APPOSING METAL STENTS. ENDOSCOPY 2018; 50: 386-395. DOI: 10.1055/A-0581-9040. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF MASSIVE HEMORRHAGE. IMDRF PATIENT CODE E2342 CAPTURES THE REPORTABLE EVENT OF POSTOPERATIVE MULTIORGAN FAILURE. IMDRF IMPACT CODE F02 CAPTURES THE REPORTABLE EVENT OF DEATH. IMDRF IMPACT CODE F19 IS BEING USED TO CAPTURE THE EMERGENT CHOLECYSTECTOMY.

    Description of Event or Problem · 0

    NOTE: PER THE ARTICLE, EITHER A COLD AXIOS STENT AND DELIVERY SYSTEM OR A HOT AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS USED. THIS REPORT PERTAINS TO THE COLD AXIOS STENT INDICATED IN THE ARTICLE. BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING BOTH COLD AXIOS STENT AND DELIVERY SYSTEM AND HOT AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM THROUGH THE ARTICLE, CUMULATIVE RISKS OF STENT MIGRATION AND GASTROINTESTINAL BLEEDING IN PATIENTS WITH LUMEN-APPOSING METAL STENTS, BY FRANCISCO JAVIER GARCIA-ALONSO, ET AL. PER THE ARTICLE, EITHER A COLD AXIOS STENT AND DELIVERY SYSTEM OR A HOT AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM WAS USED IN PATIENTS BETWEEN MAY 2011 AND JUNE 2017. TWO PATIENT DEATHS WERE NOTED WITHIN THE ARTICLE AND STATED: "FATAL OUTCOME OCCURRED IN A 67-YEAR-OLD MAN WHO PRESENTED WITH MASSIVE HEMORRHAGE 13 MONTHS AFTER LAMS PLACEMENT, IN WHOM STENT RETRIEVAL HAD BEEN REPEATEDLY POSTPONED AS HE WAS RECEIVING CHEMORADIOTHERAPY FOR ADVANCED LARYNGEAL CANCER. A PSEUDOANEURYSM WAS SUSPECTED BUT NO IMAGING WAS PERFORMED TO CONFIRM THIS. THE OTHER FATAL OUTCOME OCCURRED IN A HIGH-RISK SURGICAL PATIENT WHO PRESENTED WITH AN INTRAPERITONEAL HEMORRHAGE WITHIN 24 HOURS OF LAMS PLACEMENT FOR GALLBLADDER DRAINAGE AND UNDERWENT EMERGENT CHOLECYSTECTOMY BECAUSE OF PERITONEAL SIGNS. THE PATIENT EXPERIENCED POSTOPERATIVE MULTIORGAN FAILURE AND DIED." PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151293 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death