BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX? ESOPHAGEAL

    MDR report key: 3761192 · Received April 21, 2014

    Report

    Report Number
    3005099803-2014-01740
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K073266
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS USED IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS BEING PLACED TO TREAT A MALIGNANT ESOPHAGEAL STRICTURE. THE LESION WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE DELIVERY SYSTEM TO THE DESIRED LOCATION AND THE WHITE TIP OF THE DELIVERY SYSTEM DETACHED AND FELL INSIDE THE PATIENT. AN ATTEMPT WAS MADE TO DEPLOY THE STENT BUT THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT FULLY CONSTRAINED ON THE DELIVERY SYSTEM. THE WHITE TIP WAS REMOVED USING A FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER WALLFLEX ESOPHAGEAL 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 OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240525 WALLFLEX? ESOPHAGEAL PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516900 15898547

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention