BEUDAMED
    FDA Adverse Event Death Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6090924 · Received November 9, 2016

    Report

    Report Number
    3005099803-2016-03326
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    May 8, 2015
    Report Date
    October 14, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PCU
    PMA / PMN Number
    K140561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED WITH ADDITIONAL INFORMATION RECEIVED ON MAY 18 2017. UPDATED WITH ADDITIONAL INFORMATION RECEIVED ON MAY 18, 2017, THAT THE PATIENT'S DEATH OCCURRED AT (B)(6).

    Additional Manufacturer Narrative · 1

    THE SPECIFIC UPN AND LOT NUMBER WERE NOT REPORTED; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, IT WAS NOTED THAT 17 PATIENTS HAD A 15-MM X 10-MM AXIOS STENT PLACED, AND 13 PATIENTS HAD A 10-MM X 10-MM AXIOS STENT PLACED. JOURNAL ARTICLE: WALTER D, ET AL. " EUS-GUIDED GALL BLADDER DRAINAGE WITH A LUMEN-APPOSING METAL STENT: A PROSPECTIVE LONG-TERM EVALUATION." GUT 2015; 0: 1-3. DOI HTTP://DX.DOI.ORG/10.1136/GUTJNL-2015-309925. THE DEVICES HAVE NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE 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

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THROUGH THE ARTICLE "EUS-GUIDED GALL BLADDER DRAINAGE WITH A LUMEN-APPOSING METAL STENT: A PROSPECTIVE LONG-TERM EVALUATION" WRITTEN BY DAISY WALTER, ET AL. (SEE CITATION IN BLOCK H10). ACCORDING TO THE LITERATURE, AXIOS STENTS WERE IMPLANTED IN 30 PATIENTS AS TREATMENT FOR ACUTE CHOLECYSTITIS. 22 PATIENTS SUFFERED FROM CALCULOUS CHOLECYSTITIS. THE AGE RANGE OF ALL PATIENTS INCLUDED IN THIS STUDY WAS 68-97 YEARS, WITH A MEAN AGE OF 85 YEARS. 11 PATIENTS WERE MALE. NONE OF THE PATIENTS WERE ELIGIBLE FOR ELECTIVE CHOLECYSTECTOMY MAINLY DUE TO THEIR ONGOING HIGH SURGICAL RISK. VISUALIZATION OF THE GALLBLADDER AND DETERMINATION OF THE OPTIMAL STENT PLACEMENT SITE WAS PERFORMED USING LINEAR-ARRAY ENDOSCOPIC ULTRASOUND (EUS) AND THE STENT WAS PLACED IN THE GALLBLADDER VIA EITHER THE STOMACH OR DUODENUM. THE AXIOS STENT PLACEMENT PROCEDURE WAS PERFORMED PER PROTOCOL. ALL PATIENTS WERE TREATED WITH PROPHYLACTIC ANTIBIOTICS. TECHNICAL SUCCESS OF AXIOS STENT PLACEMENT WAS DEFINED AS SUCCESSFUL ACCESS TO THE GALLBLADDER FOLLOWED BY ADEQUATE TRANSMURAL AXIOS STENT DEPLOYMENT. TECHNICAL SUCCESS OF STENT REMOVAL WAS DEFINED AS SUCCESSFUL REMOVAL BY ESOPHAGOGASTRODUODENOSCOPY (EGD) USING A POLYPECTOMY SNARE OR RAT-ROOTH FORCEPS IN A SINGLE SESSION. TECHNICAL SUCCESS WAS ACHIEVED IN 27 OF 30 PATIENTS. STENT REMOVAL WAS ACHIEVED IN 15 OF 30 PATIENTS. STENT REMOVAL WAS NOT PERFORMED FOR THE REMAINING PATIENTS MAINLY DUE TO A POOR CLINICAL CONDITION OF THE PATIENT AND/OR PATIENT'S REFUSAL. HOWEVER, IN THREE PATIENTS SIGNIFICANT TISSUE OVERGROWTH OF THE STENT WAS EXPERIENCED, PRECLUDING STENT REMOVAL IN TWO PATIENTS. FOR THE PATIENTS IN WHICH STENT REMOVAL WAS NOT PERFORMED, THERE WERE NO STENT-RELATED COMPLICATIONS DURING THE MEAN STENT INDWELL PERIOD OF 364 DAYS. CLINICAL SUCCESS WAS DEFINED AS THE RESOLUTION OF CLINICAL PARAMETERS OF ACUTE CHOLECYSTITIS WITHIN 96 HOURS. THE CLINICAL PARAMETERS INCLUDED ABDOMINAL PAIN, BODY TEMPERATURE, WHITE BLOOD CELL COUNT, AND SERUM C-REACTIVE PROTEIN CONCENTRATION. CLINICAL SUCCESS WAS ACHIEVED IN 26 OF 27 PATIENTS. THE STUDY OBSERVED 7% STENT-RELATED OR PROCEDURE-RELATED MORTALITY. ONE PATIENT DIED OF ASPIRATION PNEUMONIA THAT WAS DEEMED TO BE RELATED TO THE STENT-PLACEMENT PROCEDURE, AND ONE PATIENT DIED OF PANCREATIC CANCER/INFECTION THAT WAS POSSIBLY RELATED TO THE STENT OR STENT PLACEMENT PROCEDURE. THE ARTICLE DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THESE PATIENTS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED. ***ADDITIONAL INFORMATION RECEIVED ON MAY 18, 2017: ACCORDING TO AN AUTHOR OF THE ARTICLE, ONLY ONE OF THE PATIENT DEATHS REPORTED IN THE ARTICLE WAS RELATED TO THE AXIOS STENT. THIS PATIENT DIED OF ASPIRATION PNEUMONIA. THE PATIENT DEATH DUE TO PANCREATIC CANCER/INFECTION WAS NOT RELATED TO THE AXIOS STENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THROUGH THE ARTICLE "EUS-GUIDED GALL BLADDER DRAINAGE WITH A LUMEN-APPOSING METAL STENT: A PROSPECTIVE LONG-TERM EVALUATION" WRITTEN BY DAISY WALTER, ET AL. ACCORDING TO THE LITERATURE, AXIOS STENTS WERE IMPLANTED IN 30 PATIENTS AS TREATMENT FOR ACUTE CHOLECYSTITIS. APPROX 22 PATIENTS SUFFERED FROM CALCULOUS CHOLECYSTITIS. THE AGE RANGE OF ALL PATIENTS INCLUDED IN THIS STUDY WAS 68-97 YEARS, WITH A MEAN AGE OF 85 YEARS. 11 PATIENTS WERE MALE. NONE OF THE PATIENTS WERE ELIGIBLE FOR ELECTIVE CHOLECYSTECTOMY MAINLY DUE TO THEIR ONGOING HIGH SURGICAL RISK. VISUALIZATION OF THE GALLBLADDER AND DETERMINATION OF THE OPTIMAL STENT PLACEMENT SITE WAS PERFORMED USING LINEAR-ARRAY ENDOSCOPIC ULTRASOUND (EUS) AND THE STENT WAS PLACED IN THE GALLBLADDER VIA EITHER THE STOMACH OR DUODENUM. THE AXIOS STENT PLACEMENT PROCEDURE WAS PERFORMED PER PROTOCOL. ALL PATIENTS WERE TREATED WITH PROPHYLACTIC ANTIBIOTICS. TECHNICAL SUCCESS OF AXIOS STENT PLACEMENT WAS DEFINED AS SUCCESSFUL ACCESS TO THE GALLBLADDER FOLLOWED BY ADEQUATE TRANSMURAL AXIOS STENT DEPLOYMENT. TECHNICAL SUCCESS OF STENT REMOVAL WAS DEFINED AS SUCCESSFUL REMOVAL BY ESOPHAGOGASTRODUODENOSCOPY (EGD) USING A POLYPECTOMY SNARE OR RAT-TOOTH FORCEPS IN A SINGLE SESSION. TECHNICAL SUCCESS WAS ACHIEVED IN 27 OF 30 PATIENTS. STENT REMOVAL WAS ACHIEVED IN 15 OF 30 PATIENTS. STENT REMOVAL WAS NOT PERFORMED FOR THE REMAINING PATIENTS MAINLY DUE TO A POOR CLINICAL CONDITION OF THE PATIENT AND/OR PATIENT'S REFUSAL. HOWEVER, IN THREE PATIENTS SIGNIFICANT TISSUE OVERGROWTH OF THE STENT WAS EXPERIENCED, PRECLUDING STENT REMOVAL IN TWO PATIENTS. FOR THE PATIENTS IN WHICH STENT REMOVAL WAS NOT PERFORMED, THERE WERE NO STENT-RELATED COMPLICATIONS DURING THE MEAN STENT INDWELL PERIOD OF 364 DAYS. CLINICAL SUCCESS WAS DEFINED AS THE RESOLUTION OF CLINICAL PARAMETERS OF ACUTE CHOLECYSTITIS WITHIN 96 HOURS. THE CLINICAL PARAMETERS INCLUDED ABDOMINAL PAIN, BODY TEMPERATURE, WHITE BLOOD CELL COUNT, AND SERUM C-REACTIVE PROTEIN CONCENTRATION. CLINICAL SUCCESS WAS ACHIEVED IN 26 OF 27 PATIENTS. THE STUDY OBSERVED 7% STENT-RELATED OR PROCEDURE-RELATED MORTALITY. ONE PATIENT DIED OF ASPIRATION PNEUMONIA THAT WAS DEEMED TO BE RELATED TO THE STENT-PLACEMENT PROCEDURE, AND ONE PATIENT DIED OF PANCREATIC CANCER/INFECTION THAT WAS POSSIBLY RELATED TO THE STENT OR STENT PLACEMENT PROCEDURE. THE ARTICLE DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THESE PATIENTS. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741132 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - MARLBOROUGH UNK894

    Patients

    Seq Age Sex Outcome Treatment
    1 Death