BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM

    MDR report key: 1843870 · Received September 24, 2010

    Report

    Report Number
    3005099803-2010-04082
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091510
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INITIALLY REPORTED LOT # 13399415 WHICH COULD NOT BE MATCHED UP WITH A DEVICE UPN. AFTER CONDUCTING A SHIP HISTORY REVIEW, LOT # 13319415 WAS FOUND TO HAVE BEEN DELIVERED TO THE CUSTOMER. THE COMPLAINANT CONFIRMED THAT THIS IS MOST PROBABLY THE CORRECT NUMBER. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THIS LOT NUMBER; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4)- NO CODE AVAILABLE (MEDICAL INTERVENTION REQUIRED).(B)(4). STENT POSITIONING PROBLEM.THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED TO TREAT A FISTULA WITHIN THE ESOPHAGUS ON SEPTEMBER 2, 2010. ACCORDING TO THE COMPLAINANT, IMMEDIATELY AFTER PLACING THE STENT AT THE STRICTURE SITE, IT MIGRATED INTO THE STOMACH. THERE WERE NO REPORTED ISSUES WITH DEPLOYING THE STENT, AND THAT IT HAD FULLY EXPANDED IN A RADIAL DIRECTION. THE STENT WAS REMOVED FROM THE PATIENT, AND A COMPETITOR'S STENT WAS PLACED. THE PHYSICIAN ADDED THAT SINCE THE TREATED CONDITION WAS A FISTULA, AND NOT A STENOSIS, THE RISK OF MIGRATION WAS HIGHER. ADDITIONALLY, THE FISTULA WAS NOT CONCURRENT WITH A TUMOR OR MALIGNANCY. 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 A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS USED TO TREAT A FISTULA WITHIN THE ESOPHAGUS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, IMMEDIATELY AFTER PLACING THE STENT AT THE STRICTURE SITE, IT MIGRATED INTO THE STOMACH. THERE WERE NO REPORTED ISSUES WITH DEPLOYING THE STENT, AND THAT IT HAD FULLY EXPANDED IN A RADIAL DIRECTION. THE STENT WAS REMOVED FROM THE PATIENT, AND A COMPETITOR'S STENT WAS PLACED. THE PHYSICIAN ADDED THAT SINCE THE TREATED CONDITION WAS A FISTULA, AND NOT A STENOSIS, THE RISK OF MIGRATION WAS HIGHER. ADDITIONALLY, THE FISTULA WAS NOT CONCURRENT WITH A TUMOR OR MALIGNANCY. 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
    1 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00516730 0013319415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention