BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6407792 · Received March 15, 2017

    Report

    Report Number
    3005099803-2017-00750
    Event Type
    Injury
    Date Received
    March 15, 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
    Product Problem
    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. (B)(4). 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. A TOTAL OF 20 PERFORATIONS WERE IDENTIFIED DURING THE STUDY, 10 OF WHICH OCCURRED AT THE STENT SITE. APPROX 7 PATIENTS WITH STENT SITE PERFORATION DIED WITHIN 30 DAYS OF THE PROCEDURE (THESE EVENTS ARE CAPTURED BY MANUFACTURER REPORT # 3005099803-2017-00747). THE REMAINING 3 PATIENTS WITH STENT SITE PERFORATION WERE SUCCESSFULLY TREATED OPERATIVELY. 10 PERFORATIONS DID NOT OCCUR AT THE STENT SITE. 8 OF THESE OCCURRED IN THE CAECUM IN CASES WHERE THE STENTING PROCEDURE WAS DEEMED TO BE A TECHNICAL FAILURE. SIX OF THESE STENTS HAD FAILED TO FULLY EXPAND AND TWO DID NOT COMPLETELY CROSS THE LESION, AND THE PATIENTS¿ PERFORATIONS WERE BELIEVED TO BE A RESULT OF FAILURE TO DECOMPRESS THE BOWEL. THE TWO REMAINING NON-STENT SITE PERFORATIONS OCCURRED GREATER THAN 6.5 CM PROXIMAL TO THE STENT AND WERE DEEMED TO BE TUMOUR RELATED. APPROX 6.6% OF PATIENTS EXPERIENCED STENT MIGRATION, AND 3.3% EXPERIENCED IN-STENT STENOSIS. 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
    189761 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 Required Intervention