BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 2091820 · Received May 17, 2011

    Report

    Report Number
    3005099803-2011-01715
    Event Type
    Injury
    Date Received
    May 17, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNAVAILABLE, THE PATIENT WAS REPORTED TO BE OVER 18 YEARS OF AGE. ALTHOUGH THE EXACT EVENT DATE (PROCEDURE DATE) IS UNAVAILABLE, THE PROCEDURE WAS REPORTED TO HAVE BEEN PERFORMED APPROXIMATELY ONE WEEK PRIOR TO (B)(6), 2011. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD AN ESOPHAGEAL STRICTURE DUE TO CANCER. AFTER DEPLOYING THE STENT, IT WAS NOTED THAT THE PROXIMAL FLARE OF THE STENT FAILED TO FULLY EXPAND. THE PHYSICIAN DECIDED TO LEAVE THE STENT IMPLANTED AND NO INTERVENTION WAS PERFORMED. THE PHYSICIAN HOPED THE STENT WOULD CONTINUE TO EXPAND OVER THE NEXT SEVERAL DAYS. THERE WERE NO PATIENT COMPLICATIONS DURING THE INITIAL STENT PLACEMENT PROCEDURE. ON (B)(6), 2011, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF PAIN. THE ATTENDING PHYSICIAN NOTED THAT THERE WAS ESOPHAGEAL BLEEDING AT THE LOCATION OF THE PROXIMAL FLARE OF THE STENT. THE STENT FLARE APPEARED FOLDED OVER AND SLIGHTLY EMBEDDED WITHIN THE TISSUE. THE BLEEDING RESOLVED ON ITS OWN. THE PAIN WAS TREATED WITH MEDICATION. THE TYPE OF MEDICATION ADMINISTERED WAS NOT PROVIDED. THE STENT WAS LEFT IMPLANTED. THE CURRENT CONDITION OF THE PATIENT WAS REPORTED TO BE "STABLE." THE PHYSICIAN PLANS TO MONITOR THE PATIENT BUT DOES NOT WANT TO PERFORM ADDITIONAL MEDICAL INTERVENTION DUE TO THE FRAGILE CONDITION OF THE PATIENT FROM THE CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY UNK477

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R