BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 1903429 · Received November 19, 2010

    Report

    Report Number
    3005099803-2010-04842
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MUCOSAL TEAR; SURGERY; ADDITIONAL NON-SURGICAL MEDICAL INTERVENTION REQUIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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 USED TO TREAT A BENIGN CONDITION SEVERAL WEEKS AGO (EXACT DATE UNKNOWN). ACCORDING TO THE COMPLAINANT, ON (B)(6) 2010, THE PHYSICIAN DECIDED TO REMOVE THE IMPLANTED STENT WITH THE HELP OF AN ARGON PLASMA COAGULATION LASER TO REMOVE TISSUE AROUND THE UNCOVERED AREA OF THE STENT. UPON REMOVAL OF THE STENT, THERE WAS CONSIDERABLE BLEEDING AND A 10CM MUCOSAL TEAR. FOLLOWING THE PROCEDURE, THE PHYSICIAN NOTED THAT THERE WAS AIR TRAPPED WITHIN THE ABDOMEN AND THE PATIENT WAS UNSTABLE, WHICH LED HIM TO BELIEVE THAT THERE WAS A PERFORATION. THE PATIENT WAS SENT TO SURGERY TO CHECK FOR A PERFORATION, BUT NONE WAS FOUND. THE PHYSICIAN ELECTED TO PLACE A FULLY COVERED STENT TO COVER THE MUCOSAL TEAR. OVER TIME, THE AIR BEGAN TO DISSIPATE AND THE PATIENT STABILIZED. THERE WAS NO ALLEGED ISSUE WITH THE STENT. THIS HAS BEEN IDENTIFIED AS AN OFF-LABEL USE. THE WALLFLEX ESOPHAGEAL STENT IS NOT INTENDED FOR USE IN BENIGN STRICTURES. FURTHERMORE, THE STENT IS CONSIDERED A PERMANENT DEVICE AND ONCE PLACEMENT IS PERMANENTLY ACHIEVED, THE STENT SHOULD NOT BE REMOVED.

    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 57 YR Required Intervention