BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3071482 · Received April 22, 2013

    Report

    Report Number
    3005099803-2013-03057
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Adverse Event
    Yes
    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 155 MM. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEVICE. DURING A FUNCTIONAL ANALYSIS, IT WAS POSSIBLE TO RETRACT THE REMAINED REMAINDER OF THE DEPLOYMENT SUTURE AND DEPLOY THE STENT WITHOUT ISSUE. NO ISSUES WERE NOTED WITH THE DEPLOYED STENT OR WITH THE SHAFT OF THE DEVICE. 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 SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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 STENT WAS ATTEMPTED TO BE IMPLANTED ON (B)(6) 2012 DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS AN ESOPHAGEAL TUMOR. DURING THE PROCEDURE, AFTER DEPLOYING APPROXIMATELY 70% THE STENT, THE DEPLOYMENT SUTURE BECAME STUCK AND THE STENT COULD NOT BE DEPLOYED. ADDITIONALLY, THE END OF THE STENT FOLDED AND LED TO INCREASE PRESSURE ON THE TRACHEA WHICH DECREASED THE PATIENT'S OXYGEN LEVEL. THE DOCTOR USED A "FOREIGN BODY" TO UNFOLD THE STENT AND PULLED IT OUT FROM THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SIZE ULTRAFLEX ESOPHAGEAL STENT DEVICE. 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. DESPITE ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED ON (B)(6) 2012 DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS AN ESOPHAGEAL TUMOR. DURING THE PROCEDURE, AFTER DEPLOYING APPROXIMATELY 70% THE STENT, THE DEPLOYMENT SUTURE BECAME STUCK AND THE STENT COULD NOT BE DEPLOYED. ADDITIONALLY, THE END OF THE STENT FOLDED AND LED TO INCREASE PRESSURE ON THE TRACHEA WHICH DECREASED THE PATIENT'S OXYGEN LEVEL. THE DOCTOR USED A "FOREIGN BODY" TO UNFOLD THE STENT AND PULLED IT OUT FROM THE PATIENT. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SIZE ULTRAFLEX ESOPHAGEAL STENT DEVICE. 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. DESPITE ATTEMPTS BOSTON SCIENTIFIC HAS BEEN UNABLE OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171851 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513860 14976506

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention