BEUDAMED
    FDA Adverse Event Death Summary report: N

    JAGWIRE

    MDR report key: 2239917 · Received September 8, 2011

    Report

    Report Number
    3005099803-2011-03016
    Event Type
    Death
    Date Received
    September 8, 2011
    Date of Event
    June 3, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE EXACT PATIENT AGE IS UNAVAILABLE, THE PATIENT WAS REPORTED TO BE OVER (B)(6) OF AGE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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 A JAGWIRE GUIDEWIRE WAS USED DURING THE PLACEMENT OF A WALLFLEX PARTIALLY-COVERED ESOPHAGEAL STENT (MFR. REPORT # 3005099803-2011-02556) THAT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE PROXIMAL ESOPHAGUS AS A RESULT OF STAGE 4 ESOPHAGEAL CANCER. THE STRICTURE WAS APPROXIMATELY 6CM IN LENGTH. ON (B)(6) 2011, THE STENT WAS PLACED SUCCESSFULLY WITH NO COMPLICATIONS. THE STRICTURE WAS NOT DILATED PRIOR TO THE STENT PLACEMENT. THE PATIENT WAS DIAGNOSED WITH ESOPHAGEAL CANCER IN (B)(6) 2010. IN (B)(6) 2010, THE PATIENT BEGAN CHEMOTHERAPY TREATMENTS OF URACIL AND CISPLATIN. IN (B)(6) 2010, THE PATIENT BEGAN RADIATION TREATMENTS. FOLLOWING THE TREATMENTS, THE PATIENT'S CONDITION WAS NOTED TO BE IMPROVED. IN (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH A RECURRENT ESOPHAGEAL STENOSIS AND WAS DEEMED INOPERABLE. THE PATIENT SUFFERED DYSPHAGIA AS A RESULT OF THE STENOSIS. ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL FOR A STENT PLACEMENT PROCEDURE. THE PATIENT HAD NO SIGNS OF A PERFORATION OR FISTULA PRIOR TO THE STENT PLACEMENT. DURING THE PROCEDURE, A .038' JAGWIRE GUIDEWIRE (THE SUBJECT OF THS REPORT) WAS ADVANCED DOWN THE ESOPHAGUS. HOWEVER, THE GUIDEWIRE PERFORATED THE ESOPHAGUS JUST DISTAL TO THE STRICTURE. THE GUIDEWIRE WAS REPOSITIONED AND THE WALLFLEX STENT SYSTEM WAS ADVANCED OVER THE GUIDEWIRE. THE STENT WAS PLACED ACROSS THE STRICTURE AND SEALED THE PERFORATION. THE STENT WAS DEPLOYED SUCCESSFULLY WITHOUT ISSUE. NO OTHER TREATMENT WAS ADMINISTERED FOR THE PERFORATION. THE PHYSICIAN NOTED THAT THE STENT HAD A SLIGHT WAIST DUE TO THE TIGHTNESS OF THE STENOSIS. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL FOR A FOLLOW-UP VISIT. IT WAS NOTED THAT THE STENT HAD FULLY EXPANDED. THE PATIENT COULD EAT AND THE PATIENT'S OVERALL CONDITION WAS IMPROVED. ON (B)(6) 2011, THE PATIENT UNDERWENT CDP CHEMOTHERAPY. ON (B)(6) 2011, THE PATIENT WAS ADMITTED INTO THE HOSPITAL. THE PATIENT COMPLAINED OF DIZZINESS AND LIGHT HEADEDNESS. IT WAS DISCOVERED THAT THE PROXIMAL END OF THE WALLFLEX STENT HAD ERODED THROUGH THE ESOPHAGUS INTO THE AORTIC ARCH CREATING AN AORTOESOPHAGEAL FISTULA. THE PATIENT SUFFERED AN UPPER GI BLEED DUE TO THE FISTULA AND WAS HYPOTENSIVE. ON (B)(6) 2011, THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT; HOWEVER, DUE TO THE LOCATION OF THE FISTULA AT THE AORTIC ARCH, THE BLEED WAS DIFFICULT TO TREAT. THE PATIENT SUBSEQUENTLY PASSED AWAY. IN THE PHYSICIAN'S ASSESSMENT, THE CAUSE OF DEATH WAS AN UPPER GI BLEED DUE TO THE AORTOESOPHAGEAL FISTULA. IN THE PHYSICIAN'S ASSESSMENT, THE GUIDEWIRE PERFORATION DURING THE INITIAL STENT PLACEMENT WAS NOT RELATED TO THE FISTULA OR DEATH AS THE PERFORATION OCCURRED DISTAL TO THE STENOSIS AND THE EROSION OCCURRED AT THE PROXIMAL END OF THE STENOSIS. THE PHYSICIAN NOTED THAT THE ESOPHAGEAL TISSUE WAS MOST LIKELY WEAKENED DUE TO THE ONGOING CHEMOTHERAPY AND RADIATION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M00556621

    Patients

    Seq Age Sex Outcome Treatment
    1 Death WALLFLEX PARTIALLY-COVERED ESOPHAGEAL STENT