BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 1914234 · Received December 3, 2010

    Report

    Report Number
    3005099803-2010-05021
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE TIP OF THE DELIVERY SYSTEM HAD DETACHED FROM THE INNER LUMEN. THE TIP WAS EVALUATED AND THERE WAS A SLIGHT FLARE OF THE DISTAL END. THE TIP WAS DISSECTED AND A MICROSCOPIC EXAMINATION FOUND TRACES OF ADHESIVE, WHICH INDICATE THAT THE TIP WAS PROPERLY ATTACHED DURING MANUFACTURING. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT INCIDENT. AS PREVIOUSLY REPORTED, THIS DEVICE WAS USED TO TRY AND TREAT A PERFORATION, WHICH IS CONSIDERED AN OFF-LABEL USE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-SURGICAL MEDICAL INTERVENTION REQUIRED. (B)(4) - CATHETER DELIVERY SYSTEM TIP DETACHED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, APPROXIMATELY 5 WEEKS BEFORE (B)(6), 2010, THE PHYSICIAN HAD PLACED A WALLFLEX ESOPHAGEAL FULLY COVERED STENT TO TREAT/SEAL AN EXISTING PERFORATION IN THE PATIENT'S ESOPHAGUS. ON (B)(6), 2010, THE PHYSICIAN REMOVED THIS STENT TO SEE IF THE PERFORATION HAD HEALED; IT HAD NOT. ALTHOUGH THE PERFORATION HAD NOT HEALED, THERE IS NO ALLEGED MALFUNCTION OF THIS DEVICE. THE PHYSICIAN DECIDED TO PLACE ANOTHER WALLFLEX ESOPHAGEAL FULLY COVERED STENT (THE SUBJECT OF THIS REPORT) TO TREAT THE PERFORATION. DURING THIS PROCEDURE ON (B)(6), 2010, WHILE ADVANCING THE STENT OVER THE GUIDEWIRE, THE PHYSICIAN NOTED SOMETHING UNUSUAL ON X-RAY. WHEN SHE PULLED THE STENT OUT OF THE PATIENT, SHE NOTED THAT THE DISTAL TIP OF THE DELIVERY SYSTEM HAD DETACHED OFF THE CATHETER. THE PHYSICIAN USED A SET OF FORCEPS TO REMOVE THE TIP FROM THE PATIENT. THE PHYSICIAN USED A HANAROSTENT (ALONG WITH THE SAME GUIDEWIRE) TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. 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 PERFORATION, 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 DURING A STENTING PROCEDURE WITHIN THE ESOPHAGUS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, APPROXIMATELY 5 WEEKS BEFORE (B)(6) 2010, THE PHYSICIAN HAD PLACED A WALLFLEX ESOPHAGEAL FULLY COVERED STENT TO TREAT/SEAL AN EXISTING PERFORATION IN THE PATIENT'S ESOPHAGUS. ON (B)(6) 2010, THE PHYSICIAN REMOVED THIS STENT TO SEE IF THE PERFORATION HAD HEALED; IT HAD NOT. ALTHOUGH THE PERFORATION HAD NOT HEALED, THERE IS NO ALLEGED MALFUNCTION OF THIS DEVICE. THE PHYSICIAN DECIDED TO PLACE ANOTHER WALLFLEX ESOPHAGEAL FULLY COVERED STENT (THE SUBJECT OF THIS REPORT) TO TREAT THE PERFORATION. DURING THIS PROCEDURE ON (B)(6) 2010, WHILE ADVANCING THE STENT OVER THE GUIDEWIRE, THE PHYSICIAN NOTED SOMETHING UNUSUAL ON X-RAY. WHEN SHE PULLED THE STENT OUT OF THE PATIENT, SHE NOTED THAT THE DISTAL TIP OF THE DELIVERY SYSTEM HAD DETACHED OFF THE CATHETER. THE PHYSICIAN USED A SET OF FORCEPS TO REMOVE THE TIP FROM THE PATIENT. THE PHYSICIAN USED A HANAROSTENT (ALONG WITH THE SAME GUIDEWIRE) TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. 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 PERFORATION, 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 M00516740 13726871

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention SUPER STIFF JAGWIRE