BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 10385677 · Received August 10, 2020

    Report

    Report Number
    3005099803-2020-03231
    Event Type
    Injury
    Date Received
    August 10, 2020
    Date of Event
    February 1, 2016
    Report Date
    August 10, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PCU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RANGE OF AGES IN THE HOT AXIOS GROUP WAS 22-83 YEARS OLD. IN THE HOT AXIOS GROUP THERE WERE 11 FEMALES AND 20 MALES. IN THE HOT AXIOS GROUP THERE WERE 3 BLACK PATIENTS, 2 HISPANIC PATIENTS, AND 26 WHITE PATIENTS. THE EVENT DATES ARE UNKNOWN. THE PROCEDURES WERE PERFORMED BETWEEN FEBURARY 2016 AND MARCH 2017. APPROXIMATED BASED ON THE MONTH AND YEAR OF THE FIRST PROCEDURE. THE UPNS AND LOT NUMBERS WERE NOT REPORTED; THEREFORE, THE MANUFACTURE DATES AND EXPIRATION DATES ARE UNKNOWN. LITERATURE SOURCE: BANG, JI YOUNG, ET AL. "NON-SUPERIORITY OF LUMEN-APPOSING METAL STENTS OVER PLASTIC STENTS FOR DRAINAGE OF WALLED-OFF NECROSIS IN A RANDOMISED TRIAL" GUT, VOL. 68, NO. 7, 1 JUNE 2018, PP. 1200-1209, DOI HTTP:// DX.DOI.ORG/10.1136/GUTJNL- 2017- 315335. (B)(4). THE DEVICES HAVE NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES REFERENCED IN THE LITERATURE ARTICLE. REFER TO MANUFACTURER REPORT NUMBER (B)(4) FOR THE FIRST HOT AXIOS AND (B)(4) FOR THE SECOND ADVANIX PANCREATIC. BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS INVOLVING HOT AXIOS STENTS THROUGH THE ARTICLE "NON-SUPERIORITY OF LUMEN-APPOSING METAL STENTS OVER PLASTIC STENTS FOR DRAINAGE OF WALLED-OFF NECROSIS IN A RANDOMISED TRIAL" WRITTEN BY JI YOUNG BANG, ET AL. ACCORDING TO THE LITERATURE, THE AIM OF THE STUDY WAS TO COMPARE EFFICACY OF LUMEN-APPOSING METAL STENTS (LAMS) (HOT AXIOS) AND PLASTICS STENTS FOR DRAINAGE OF WALLED-OFF NECROSIS (WON) AS LAMS ADVANTAGE OVER PLASTIC STENTS IS UNCLEAR. BETWEEN FEBRUARY 2016 AND MARCH 2017, 80 PATIENTS WERE SCREENED AND 60 PATIENTS WITH WON UNDERWENT RANDOMIZATION: 31 PATIENTS IN THE LAMS GROUP AND 29 PATIENTS IN THE PLASTIC GROUP. THE PLASTIC STENT USED WAS REPORTED TO BE A 7FR 4CM BOSTON SCIENTIFIC DOUBLE PIGTAIL STENT. THE ETIOLOGY OF PANCREATITIS FOR THE PATIENTS WHO RECEIVED A HOT AXIOS STENT IS AS FOLLOWS: 29% ALCOHOL, 19.4% GALLSTONES, IDIOPATHIC (38.7%), OTHER (12.9%) AND A RANGE OF DEGREE OF NECROSIS OF 20-70%. THE WON WAS LOCATED IN THE HEAD/UNCINATE OF THE PANCREAS IN 29% OF CASES AND IN THE BODY/TAIL IN 71% OF CASES. THE AXIOS WAS PLACED TRANSGASTRICALLY IN 77.4% OF CASES AND TRANSDUODENALLY IN 22.6% OF CASES. HOT AXIOS RELATED EVENTS WERE ENCOUNTERED IN 10 OUT OF 31 PATIENTS. EIGHT OF THE 10 WERE OBSERVED IN THE FIRST 5 MONTHS. IN TWO PATIENTS, THE LAMS WERE FOUND BURIED UNDER THE GASTRIC MUCOSA ON FLUOROSCOPY WHEN THEY PRESENTED FOR STENT REMOVAL AT 5 AND 6 WEEKS POSTPROCEDURE. IN ONE PATIENT, ENDOSCOPIC STENT RETRIEVAL RESULTED IN MASSIVE BLEEDING REQUIRING INTERVENTIONAL RADIOLOGY (IR)-GUIDED COIL EMBOLISATION. IN THE OTHER PATIENT, THE BURIED LAMS WAS RETRIEVED USING BIOPSY FORCEPS AFTER TRANSMURAL TRACT DILATION. THREE PATIENTS PRESENTED WITH SEVERE GI BLEEDING REQUIRING INTENSIVE CARE UNIT ADMISSIONS AND BLOOD TRANSFUSIONS AFTER 3 (N=1) AND 5 WEEKS (N=2) POSTSTENT PLACEMENT. A CT ANGIOGRAM CONFIRMED PSEUDOANEURYSMS IN ALL THREE PATIENTS AND WERE MANAGED BY IR-GUIDED COIL EMBOLISATION. THREE PATIENTS PRESENTED WITH OBSTRUCTIVE JAUNDICE AT 5 (N=1) AND 6 WEEKS (N=2) POST-LAMS PLACEMENT. AT ERCP, A DISTAL BILIARY STRICTURE WAS OBSERVED SECONDARY TO MECHANICAL COMPRESSION INDUCED BY THE LAMS THAT HAD BEEN DEPLOYED VIA THE DUODENAL BULB. THE LAMS WERE REMOVED AND ALL PATIENTS WERE TREATED SUCCESSFULLY BY BILIARY SPHINCTEROTOMY WITH OR WITHOUT TEMPORARY BILIARY STENT PLACEMENT. FOLLOWING A CHANGE TO THE STUDY PROTOCOL, WHERE AN ADDITIONAL CT WAS OBTAINED AT 3 WEEKS POST PLACEMENT FOLLOWED BY STENT REMOVAL IF THE WON HAD RESOLVED, ONLY TWO STENT-RELATED ADVERSE EVENTS WERE OBSERVED. ONE WAS A STENT MIGRATION INTO THE GI TRACT WHICH MANIFESTED FIRST AS GASTRIC OUTLET OBSTRUCTION WHEN THE LAMS IMPACTED THE PYLORUS, THEN AS SMALL BOWEL OBSTRUCTION WHEN IT IMPACTED THE JEJUNUM AND THEN FINALLY AS FAECAL IMPACTION WHEN IT OCCLUDED THE RECTOSIGMOID JUNCTION. THE STENT WAS RETRIEVED AT SIGMOIDOSCOPY USING RAT TOOTH FORCEPS AND NO UNDERLYING COLONIC STRICTURE WAS IDENTIFIED. THE OTHER INVOLVED LOCALISED BLEEDING IN THE GASTRIC MUCOSA WHEN THE WON WAS ACCESSED WITH THE TIP OF THE ELECTROCAUTERY- ENHANCED DELIVERY SYSTEM. THE PATIENT WAS MANAGED ENDOSCOPICALLY BY INJECTION OF EPINEPHRINE AND APPLICATION OF CAUTERY. THE STUDY CONCLUDED, THEY DID NOT OBSERVE ANY SIGNIFICANT DIFFERENCE IN THE PRIMARY OR SECONDARY OUTCOMES BETWEEN PATIENTS TREATED WITH LAMS OR PLASTIC STENTS EXCEPT FOR INITIAL PROCEDURE, DURATION WITH LAMS BEING SHORTER, AND THE RATE OF STENT-RELATED ADVERSE EVENTS PRIOR TO PROTOCOL CHANGE. ADDITIONALLY THE STUDY FOUND THAT GIVEN THE FASTER RESOLUTION OF WON, TO MINIMIZE ADVERSE EVENTS, PATIENTS UNDERGOING LAMS PLACEMENT SHOULD UNDERGO FOLLOW-UP IMAGING AT 3 WEEKS WITH STENT REMOVAL IF THE FLUID COLLECTION HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851844 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention