BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010

    MDR report key: 6403992 · Received March 14, 2017

    Report

    Report Number
    3005099803-2017-00747
    Event Type
    Death
    Date Received
    March 14, 2017
    Date of Event
    June 3, 2016
    Report Date
    February 20, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEAN AGE OF PATIENTS INCLUDED IN THE STUDY WAS 72 YEARS (RANGE 28-98 YEARS). THE STUDY INCLUDED 249 PATIENTS: 126 MALES AND 123 FEMALES. THE SPECIFIC UPNS AND LOT NUMBERS WERE NOT REPORTED; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. LITERATURE SOURCE: LITTLE, M. W., ET AL. "TECHNICAL AND CLINICAL OUTCOMES FOLLOWING COLONIC STENTING: A SEVEN-YEAR ANALYSIS OF 268 PROCEDURES." CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY 39.10 (2016): 1471-1478. DOI HTTP://DX.DOI.ORG/ 10.1007/S00270-016-1391-5. 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

    BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THROUGH THE ARTICLE "TECHNICAL AND CLINICAL OUTCOMES FOLLOWING COLONIC STENTING: A SEVEN-YEAR ANALYSIS OF 268 PROCEDURES" WRITTEN BY M.W. LITTLE, ET AL. ACCORDING TO THE LITERATURE, THE AIM OF THIS STUDY WAS TO ASSESS THE FACTORS CONTRIBUTING TO THE TECHNICAL AND CLINICAL SUCCESS OF COLORECTAL STENTING FOR LARGE BOWEL OBSTRUCTION. IN ALL CASES, PATIENTS WERE IMPLANTED WITH A WALLFLEX COLONIC STENT BETWEEN 2006 AND 2013. THE MAJORITY OF PATIENT STRICTURES WERE DUE TO MALIGNANT DISEASE (244/268 STRICTURES - 91%), WITH 19/268 (17%) RESULTING FROM EXTRINSIC COMPRESSION. 24/268 (9%) WERE DIVERTICULAR STRICTURES. SEVEN (7) PATIENTS EXPERIENCED A PERFORATION AT THE STENT SITE AND DIED WITHIN 30 DAYS OF THE 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
    185586 WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010 STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY UNK476

    Patients

    Seq Age Sex Outcome Treatment
    1 Death