BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM

    MDR report key: 1880979 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04523
    Event Type
    Death
    Date Received
    October 25, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL AND FUNCTIONAL EXAMINATION OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, A MANUFACTURING REVIEW WAS COMPLETED TO FURTHER INVESTIGATE THE REPORTED STENT COVER DAMAGE. THIS REVIEW CONCLUDED THAT ON REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS BATCH NO ISSUES WERE NOTED AND ALL UNITS SHIPPED FOR THIS BATCH PASSED ALL PROCESS INSPECTIONS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED THAT COULD BE RELATED TO THIS COMPLAINT. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER WAS PERFORMED AND CONCLUDED THERE WERE NO OTHER COMPLAINTS REPORTED FOR THIS LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS NOT USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE ULTRAFLEX COVERED AND UNCOVERED ESOPHAGEAL AND ESOPHAGEAL NG STENT SYSTEM IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS ONLY. THE ULTRAFLEX COVERED ESOPHAGEAL AND THE ESOPHAGEAL NG STENT SYSTEM ARE ALSO BOTH INDICATED FOR OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULA. THIS STENT WAS PLACED TO TREAT AN IATROGENIC LEAK AND NOT TO TREAT A STRICTURE. THE MOST PROBABLE ROOT CAUSE IS USE/USER ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4) (COVER) (B)(4) (HOLE) FOR THE REPORTED ISSUE OF STENT COVERING DAMAGE.THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT 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 TWO ULTRAFLEX ESOPHAGEAL COVERED STENTS WERE USED DURING A PROCEDURE WITHIN A PATIENT WITH A STRICTURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE FIRST STENT (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-04522) WAS POSITIONED ABOVE THE PYLORUS IN THE ESOPHAGUS. DURING DEPLOYMENT, AFTER SEVENTY FIVE PERCENT OF THE STENT WAS DEPLOYED, RESISTANCE WAS ENCOUNTERED AND THE STENT WAS UNABLE TO BE IMPLANTED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. A SECOND ULTRAFLEX ESOPHAGEAL COVERED STENT (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-04523) WAS IMPLANTED SUCCESSFULLY. TWENTY FOUR HOURS POST PROCEDURE, THE STENT WAS VISUALLY EXAMINED, AND THE PHYSICIAN BELIEVED THAT THE STENT COVERING WAS 'BROKEN.' ADDITIONAL INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC, THAT THE PATIENT HAS SINCE PASSED AWAY. DESPITE NUMEROUS 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. ***THE FOLLOWING INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC ON (B)(6) 2010.*** DURING THE ESOPHAGOGASTRODUODENOSCOPY PROCEDURE ON (B)(6) 2010 THE PATIENT'S ANATOMY WAS NOT DILATED. THERE WERE NO ISSUES REMOVING THE PARTIALLY DEPLOYED STENT FROM THE PATIENT, (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-04522). THE INDICATION FOR THE STENT PLACEMENT WAS NOT A STRICTURE, BUT AN IATROGENIC GASTRIC LEAK. AFTER THE STENT WAS PLACED (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-04523), LEAKAGE STOPPED FASTER; HOWEVER LEAKAGE REOCCURRED 24 HOURS LATER. ON (B)(6) 2010, 48 HOURS AFTER STENT PLACEMENT, AN ENDOSCOPIC PROCEDURE SHOWED EXTENSIVE DAMAGE/DISSOLUTION TO THE STENT COVERING. A SECOND ULTRAFLEX STENT WAS PLACED TO RESOLVE THE EVENT. THERE WAS NO MALFUNCTION OF THE SECOND ULTRAFLEX STENT. AFTER 4 DAYS, FURTHER TREATMENT WAS STOPPED DUE TO 'INCURABLE MALIGNANCY' AND THE 'DETERIORATING' CONDITION OF THE PATIENT. ON (B)(6) 2010 THE PATIENT PASSED AWAY. NO AUTOPSY WAS PERFORMED; HOWEVER THE CAUSE OF DEATH WAS REPORTED AS 'GENERAL MALAISE.' IN THE PHYSICIAN'S ASSESSMENT, LEAKAGE SINCE (B)(6) MAY HAVE CONTRIBUTED TO THE DECREASE OF THE PATIENT'S GENERAL CONDITION. IN THE PHYSICIAN'S ASSESSMENT, THE DAMAGE TO THE COVERING OF THE STENT DID CONTRIBUTE TO THE PATIENT'S DEATH. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE CONTRIBUTING CO-MORBIDITIES. IT IS IMPORTANT TO NOTE THAT THE ULTRAFLEX COVERED AND UNCOVERED ESOPHAGEAL AND ESOPHAGEAL NG STENT SYSTEM IS INTENDED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AND/OR EXTRINSIC MALIGNANT TUMORS ONLY. THE ULTRAFLEX COVERED ESOPHAGEAL AND THE ESOPHAGEAL NG STENT SYSTEM ARE ALSO BOTH INDICATED FOR OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO ULTRAFLEX ESOPHAGEAL COVERED STENTS WERE USED DURING A PROCEDURE WITHIN A PATIENT WITH A STRICTURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST STENT (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-04522) WAS POSITIONED ABOVE THE PYLORUS IN THE ESOPHAGUS. DURING DEPLOYMENT, AFTER SEVENTY FIVE PERCENT OF THE STENT WAS DEPLOYED, RESISTANCE WAS ENCOUNTERED AND THE STENT WAS UNABLE TO BE IMPLANTED. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. A SECOND ULTRAFLEX ESOPHAGEAL COVERED STENT (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-04523) WAS IMPLANTED SUCCESSFULLY. TWENTY FOUR HOURS POST PROCEDURE, THE STENT WAS VISUALLY EXAMINED, AND THE PHYSICIAN BELIEVED THAT THE STENT COVERING WAS "BROKEN". ADDITIONAL INFORMATION WAS REPORTED TO BOSTON SCIENTIFIC, THAT THE PATIENT HAS SINCE PASSED AWAY. DESPITE NUMEROUS 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
    1 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513750 13193463

    Patients

    Seq Age Sex Outcome Treatment
    1 Death