BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3981543 · Received August 5, 2014

    Report

    Report Number
    3005099803-2014-02722
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE DISTAL END OF THE STENT WAS PARTIALLY DEPLOYED BY 80MM. IT WAS NOTED THAT AT THE PROXIMAL END OF THE STENT THE DEPLOYMENT SUTURE WAS ENTANGLED WITH THE SUTURE THAT WAS EXITING THE HUB. DURING ANALYSIS IT WAS NOT POSSIBLE TO RETRACT THE DEPLOYMENT SUTURE THAT WAS EXITING THE HUB DUE TO THIS ENTANGLEMENT. THERE WAS HOWEVER NO ISSUE IN RETRACTING THE SUTURE FROM THE POINT OF RELEASE FROM THE STENT BY RETRACTING THE SUTURE CLOSE TO THE RELEASE POINT. THE SUTURE WAS THEN CUT IN ORDER TO UNTANGLE THE 2 SECTIONS AND IT WAS NOW POSSIBLE TO FULLY RETRACT THE SUTURE AND FULLY DEPLOY THE STENT WITHOUT ISSUE. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE NOTED ISSUE WAS LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE SINCE IF THIS ENTANGLEMENT HAD OCCURRED PRIOR TO THE PROCEDURE IT WOULD NOT HAVE BEEN POSSIBLE TO DEPLOY THE STENT AT ALL. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. 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

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER, IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. REPORTED EVENT OF STENT PARTIALLY DEPLOYED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON 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 AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT WAS USED IN THE LOWER THIRD PORTION OF THE ESOPHAGUS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING USED TO TREAT A 7CM LESION DUE A MALIGNANT TUMOR. REPORTEDLY, THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE PHYSICIAN PARTIALLY DEPLOYED THE STENT BY 4CM WHEN THE DEPLOYMENT SUTURE COULD NO LONGER BE RELEASED. AS REPORTED, ATTEMPTS WERE MADE TO FULLY DEPLOY THE STENT BUT WERE UNSUCCESSFUL. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT WAS USED IN THE LOWER THIRD PORTION OF THE ESOPHAGUS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING USED TO TREAT A 7CM LESION DUE A MALIGNANT TUMOR. REPORTEDLY, THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE PHYSICIAN PARTIALLY DEPLOYED THE STENT BY 4CM WHEN THE DEPLOYMENT SUTURE COULD NO LONGER BE RELEASED. AS REPORTED, ATTEMPTS WERE MADE TO FULLY DEPLOY THE STENT BUT WERE UNSUCCESSFUL. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL DISTAL RELEASE STENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456809 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513740 0016676576

    Patients

    Seq Age Sex Outcome Treatment
    1