BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3994339 · Received August 8, 2014

    Report

    Report Number
    3005099803-2014-02694
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). EVALUATION REPORT OF STENT. PARTIALLY DEPLOYED. EVALUATION REPORT OF STENT. FAILED TO EXPAND. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND OUT THAT THE DISTAL END OF THE STENT WAS PARTIALLY DEPLOYED BY 3 MM. DURING ANALYSIS IT WAS POSSIBLE TO FULLY DEPLOY THE STENT WITHOUT ISSUE. THE STENT HOWEVER DID NOT FULLY EXPAND AFTER DEPLOYMENT. A MINIMUM OUTSIDE DIAMETER OF 6.77MM WAS RECORDED USING A DIGITAL SNAP GAUGE. AFTER A PERIOD OF TWO DAYS THE DEVICE WAS SEALED IN A PLASTIC BAG WITH 250MM OF WATER WHICH WAS HEATED TO 37 DEGREES CELSIUS INDEPENDENTLY. A MINIMUM OUTSIDE DIAMETER OF 10MM WAS RECORDED USING A DIGITAL VERNIER. THE STENT DIAMETER SHOULD BE 18.0 ± 1.5 MM. THE INVESTIGATOR OBSERVED A BEND IN THE SHAFT AT THE PROXIMAL END OF THE COVERED STENT. IT WAS ALSO NOTED THAT THE CATHETER WAS KINKED AT VARIOUS LOCATIONS ALONG ITS LENGTH. GIVEN THE EVENT DESCRIPTION AND THE CONDITION OF THE RETURNED DEVICE, THERE ISN'T ENOUGH INFORMATION TO DETERMINE A PROBABLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT WAS USED IN THE MID ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A STRICTURE. REPORTEDLY, THE PATIENT¿S ANATOMY WAS NOT TORTUOUS. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE STENT DELIVERY SYSTEM INTO THE TIGHT STRICTURE. IT WAS NOTED THAT THE STENT DELIVERY SYSTEM BUCKLED AND COULD NOT PASS THE STRICTURE. THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM AND DILATED THE STRICTURE TO 10 MM USING A SAVARY DILATOR. THE STENT WAS REINSERTED AND THE SAME ISSUE OCCURRED. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND STENT FROM THE PATIENT. REPORTEDLY, THE PATIENT HAD MINOR BLEEDS AND BRUISES IN THE MOUTH AND UPPER ESOPHAGUS DUE TO THE PRESSURE APPLIED BY THE CATHETER WHILE TRYING TO DEPLOY THE STENT. ACCORDING TO THE PHYSICIAN, THE MINOR BLEEDS AND BRUISES WOULD SELFHEAL AND THERE WERE NO INTERVENTIONS DONE TO ADDRESS THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR-REPORTABLE EVENT BASED ON INVESTIGATION RESULTS WHICH REVEALED THE STENT WAS RECEIVED PARTIALLY DEPLOYED AND THE STENT FAILED TO EXPAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467228 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513750 16574593

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR