BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 2022603 · Received March 17, 2011

    Report

    Report Number
    3005099803-2011-00826
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 6, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED AND THE CATHETER WAS KINKED AT SEVERAL LOCATIONS ALONG THE WORKING LENGTH. IN ADDITION, THE BLUE OUTER SHEATH WAS ACCORDIONED AT MULTIPLE LOCATIONS. DURING ANALYSIS, IT WAS POSSIBLE TO RETRACT THE OUTER SHEATH BY HAND AND PARTIALLY DEPLOY, RE-CONSTRAIN, AND FULLY DEPLOY THE STENT WITHOUT ISSUE. THERE WAS NO ISSUE IN THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. THERE WERE NO ISSUES NOTED WITH THE PROFILE OF THE DEPLOYED STENT; HOWEVER, THE INNER LUMEN WAS KINKED. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT THAT DIFFICULTY WAS ENCOUNTERED CROSSING THE STRICTURE. A LABELING REVIEW IDENTIFIED THAT THE DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE DFU / PRODUCT LABEL STATES "THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS. THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM IS CONTRAINDICATED FOR PLACEMENT IN ESOPHAGEAL STRICTURES CAUSED BY BENIGN TUMORS, AS THE LONG-TERM EFFECTS OF THE STENT IN THE ESOPHAGUS ARE UNKNOWN." HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS USED TO TREAT A BENIGN ANASTOMOTIC STRICTURE THAT RESULTED FROM BARIATRIC SURGERY. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS USER/USE ERROR. A SEARCH OF THE COMPLAINT DATABASE FOUND THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED TO TRY AND TREAT A BENIGN ANASTOMOTIC STRICTURE THAT RESULTED FROM BARIATRIC SURGERY. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A STRICTURE BETWEEN THE ESOPHAGUS AND DUODENUM. DUE TO THE TORTUOUS NATURE OF THE ANATOMY, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DEVICE THROUGH THE STRICTURE. THE PHYSICIAN REMOVED THE DEVICE AND PERFORMED A SUCCESSFUL BALLOON DILATATION; HOWEVER, DESPITE THIS, THE STENT STILL COULD NOT BE ADVANCED THROUGH. THE PHYSICIAN ABORTED THE PROCEDURE, AND ULTIMATELY DECIDED TO TRY A DIFFERENT SURGICAL SOLUTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT SHOULD BE NOTED THAT THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS. AS THIS WAS USED TO TREAT A BENIGN ANASTOMOTIC STRICTURE, THIS HAS BEEN IDENTIFIED AS AN OFF-LABEL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED TO TRY AND TREAT A BENIGN ANASTOMOTIC STRICTURE THAT RESULTED FROM BARIATRIC SURGERY. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A STRICTURE BETWEEN THE ESOPHAGUS AND DUODENUM. DUE TO THE TORTUOUS NATURE OF THE ANATOMY, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DEVICE THROUGH THE STRICTURE. THE PHYSICIAN REMOVED THE DEVICE AND PERFORMED A SUCCESSFUL BALLOON DILATATION; HOWEVER, DESPITE THIS, THE STENT STILL COULD NOT BE ADVANCED THROUGH. THE PHYSICIAN ABORTED THE PROCEDURE, AND ULTIMATELY DECIDED TO TRY A DIFFERENT SURGICAL SOLUTION. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. IT SHOULD BE NOTED THAT THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS, AND OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULAS. AS THIS WAS USED TO TREAT A BENIGN ANASTOMOTIC STRICTURE, THIS HAS BEEN IDENTIFIED AS AN OFF-LABEL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516750 0013973694

    Patients

    Seq Age Sex Outcome Treatment
    1 CRE BALLOON