BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX ¿ DUODENAL

    MDR report key: 2802846 · Received October 24, 2012

    Report

    Report Number
    3005099803-2012-05007
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    MUM
    PMA / PMN Number
    K062750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS FULLY MOUNTED. IT WAS NOTED THAT THE STENT WIRES HAD NOT PERFORATED THE OUTER SHEATH. THE DISTAL HANDLE WAS DETACHED FROM THE OUTER SHEATH. THE OUTER SHEATH WAS STRETCHED AND ACCORDIONED FOR A DISTANCE OF APPROXIMATELY 150 MM FROM THE HANDLE BREAK. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE TENSILE FORCE HAVING BEEN APPLIED TO THE SHAFT. THE STAINLESS STEEL SHAFT WAS KINKED AT SEVERAL LOCATIONS ALONG ITS LENGTH. DURING ANALYSIS IT WAS NOT POSSIBLE TO RETRACT THE OUTER SHEATH TO DEPLOY THE STENT SO THE SHAFT WAS DISSECTED PROXIMAL TO THE STENT AND THE INNER SHAFT AND STENT WERE WITHDRAWN FROM THE OUTER SHEATH. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT OR THE INNER SHAFT. THE OUTER SHEATH WAS UNABLE TO BE MOVED PROXIMALLY OR DISTALLY. THE OUTER SHEATH WAS DISSECTED LONGITUDINALLY AND IT WAS NOTED THAT SOME OF THE POLYTETRAFLUOROETHYLENE (PTFE) COATING HAD DETACHED FROM THE INSIDE OF THE OUTER SHEATH. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILED TO INDICATE A ROOT CAUSE OR PROBABLE ROOT CAUSE. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS UNDETERMINABLE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF CATHETER PERFORATED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 ENTERAL DUODENAL STENT WAS ATTEMPTED TO BE IMPLANTED ON (B)(6) 2012 DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE WALLFLEX ENTERAL DUODENAL STENT WAS BEING PLACED TO TREAT A 5 CM STRICTURE DUE TO STOMACH CANCER. THE PATIENT ANATOMY WAS REPORTED TO BE TORTUOUS. DURING THE PROCEDURE A DUODENOSCOPY WAS PERFORMED AND A PYLORIC STRICTURE WAS SEEN FLUOROSCOPICALLY. THE PHYSICIAN DECIDED TO DEPLOY THE STENT. THE WALLFLEX ENTERAL DUODENAL STENT WAS LOADED ON THE GUIDEWIRE AND WHEN ATTEMPTING TO DEPLOY THE STENT, THE STENT WIRE PERFORATED THE OUTER SHEATH AND THE STENT COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT COMPLETELY (THE STENT WAS FULLY CONSTRAINED IN THE CATHETER) AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SIZE WALLFLEX ENTERAL DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "STABLE" POST PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ENTERAL DUODENAL STENT WAS ATTEMPTED TO BE IMPLANTED ON (B)(6) 2012, DURING A STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE WALLFLEX ENTERAL DUODENAL STENT WAS BEING PLACED TO TREAT A 5CM STRICTURE DUE TO STOMACH CANCER. THE PATIENT ANATOMY WAS REPORTED TO BE TORTUOUS. DURING THE PROCEDURE A DUODENOSCOPY WAS PERFORMED AND A PYLORIC STRICTURE WAS SEEN FLUOROSCOPICALLY. THE PHYSICIAN DECIDED TO DEPLOY THE STENT. THE WALLFLEX ENTERAL DUODENAL STENT WAS LOADED ON THE GUIDEWIRE AND WHEN ATTEMPTING TO DEPLOY THE STENT, THE STENT WIRE PERFORATED THE OUTER SHEATH AND THE STENT COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED FROM THE PATIENT COMPLETELY (THE STENT WAS FULLY CONSTRAINED IN THE CATHETER) AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SIZE WALLFLEX ENTERAL DUODENAL STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE "STABLE" POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLFLEX ¿ DUODENAL STENT,METALLIC,EXPANDABLE,DUODENAL MUM BOSTON SCIENTIFIC - GALWAY M00565030 0015152179

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR