BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLEX

    MDR report key: 1740296 · Received June 29, 2010

    Report

    Report Number
    3005099803-2010-02984
    Event Type
    Death
    Date Received
    June 29, 2010
    Report Date
    June 4, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K963241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (6). (B) (4) - NO CODE AVAILABLE (GASTROINTESTINAL BLEEDING) THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. 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 THROUGH A LITERATURE REVIEW THAT A COVERED ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE STENT WAS PLACED ON AN UNKNOWN DATE FOR A MALIGNANT BRONCHOESOPHAGEAL FISTULA. ON AN UNKNOWN DATE, THE STENT BECAME INFECTED AND THE PATIENT PRESENTED WITH RECURRENT PNEUMONIA. THE STENT WAS REMOVED SUCCESSFULLY AND THE FISTULA WAS INJECTED WITH FIBRIN GLUE AND RESTENTED WITH A SILICONE STENT. FOLLOW UP BRONCHOSCOPY REVEALED A PATENT SILICONE STENT. WHILE HOSPITALIZED, THE PATIENT PRESENTED WITH SEPTIC SHOCK AND SEVERE GASTROINTESTINAL BLEEDING. THE PATIENT EXPIRED THREE WEEKS LATER DUE TO PERSISTENT SHOCK. THE PATIENT'S DEATH WAS NOT CLEARLY ATTRIBUTABLE TO THE REMOVAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THROUGH A LITERATURE REVIEW THAT A COVERED ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE STENT WAS PLACED ON AN UNKNOWN DATE FOR A MALIGNANT BRONCHOESOPHAGEAL FISTULA. ON AN UNKNOWN DATE, THE STENT BECAME INFECTED AND THE PATIENT PRESENTED WITH RECURRENT PNEUMONIA. THE STENT WAS REMOVED SUCCESSFULLY AND THE FISTULA WAS INJECTED WITH FIBRIN GLUE AND RESTENTED WITH A SILICONE STENT. FOLLOW UP BRONCHOSCOPY REVEALED A PATENT SILICONE STENT. WHILE HOSPITALIZED, THE PATIENT PRESENTED WITH SEPTIC SHOCK AND SEVERE GASTROINTESTINAL BLEEDING. THE PATIENT EXPIRED THREE WEEKS LATER DUE TO PERSISTENT SHOCK. THE PATIENT'S DEATH WAS NOT CLEARLY ATTRIBUTABLE TO THE REMOVAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED (B)(6), 2010. ACCORDING TO THE TREATING PHYSICIAN, THE COMPLICATIONS THAT OCCURRED WERE NOT A RESULT OF AN ISSUE WITH THE DEVICE, EITHER IN FUNCTION OR CONTAMINATION. THE ORIGINAL PROCEDURE DATE WAS APPROXIMATELY 3-4 YEARS AGO.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THROUGH A LITERATURE REVIEW THAT A COVERED ULTRAFLEX TRACHEOBRONCHIAL STENT WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE STENT WAS PLACED ON AN UNKNOWN DATE FOR A MALIGNANT BRONCHOESOPHAGEAL FISTULA. ON AN UNKNOWN DATE, THE STENT BECAME INFECTED AND THE PATIENT PRESENTED WITH RECURRENT PNEUMONIA. THE STENT WAS REMOVED SUCCESSFULLY AND THE FISTULA WAS INJECTED WITH FIBRIN GLUE AND RESTENTED WITH A SILICONE STENT. FOLLOW UP BRONCHOSCOPY REVEALED A PATENT SILICONE STENT. WHILE HOSPITALIZED, THE PATIENT PRESENTED WITH SEPTIC SHOCK AND SEVERE GASTROINTESTINAL BLEEDING. THE PATIENT EXPIRED THREE WEEKS LATER DUE TO PERSISTENT SHOCK. THE PATIENT'S DEATH WAS NOT CLEARLY ATTRIBUTABLE TO THE REMOVAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED (B)(6) 2010. ACCORDING TO THE TREATING PHYSICIAN, THE COMPLICATIONS THAT OCCURRED WERE NOT A RESULT OF AN ISSUE WITH THE DEVICE, EITHER IN FUNCTION OR CONTAMINATION. THE ORIGINAL PROCEDURE DATE WAS APPROXIMATELY 3-4 YEARS AGO. ADDITIONAL INFORMATION RECEIVED (B)(6) 2011. THE PRIMARY PHYSICIAN, (B)(6) STATED THAT THE STENT WAS REMOVED BECAUSE IT WAS SEEDED FROM BACTERIA ORIGINATING FROM THE PATIENT. HE FURTHER ADDED, "THE TERM "INFECTED STENT" MAY IN FACT LEAD TO MISINTERPRETATION. IT WAS NOT OUR OPINION, NOR DO WE WANT TO INSINUATE THAT THIS REPRESENTED A PRIMARY FAILURE OF THE STENT, OR A PROBLEM IN STENT DESIGN, BUT RATHER CONSIDER THIS AN UNFORTUNATE EVENT DUE TO THE PATIENT'S UNDERLYING MEDICAL PROBLEMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY UNK449

    Patients

    Seq Age Sex Outcome Treatment
    1 Death