BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX¿ ESOPHAGEAL NG

    MDR report key: 2250086 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03065
    Event Type
    Injury
    Date Received
    September 15, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 22, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSICIAN FIRST NAME: (B)(6). ONLY THE DEPLOYED STENT WAS RECEIVED FOR ANALYSIS. A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT COVER WAS MISSING. IT WAS NOTED THAT THE GREEN RETENTION SUTURE THREAD ON THE FLARED END OF THE STENT WAS BROKEN. MICROSCOPIC EXAMINATION OF THE THREAD NOTED THAT IT APPEARED FRAYED AT THE POINT OF BREAK. NO OTHER ISSUES WERE NOTED WITH THE STENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH NUMBER. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE CLASSIFICATION IS UNDETERMINABLE.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF STENT COVER DISINTEGRATED. THE COMPLAINT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER; HOWEVER, A FAILURE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON RECEIPT OF THE FAILURE ANALYSIS, 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 THAT AN ULTRAFLEX COVERED ESOPHAGEAL STENT WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD AN ESOPHAGOGASTROSTOMY DUE TO AN ESOPHAGEAL MALIGNANCY. DURING THE SURGERY, A PORTION OF THE STOMACH WAS RESECTED. FOLLOWING THE SURGERY, A 4MM LEAK OCCURRED AT THE SITE OF THE ANASTOMOSIS. ON (B)(6) 2011, THE STENT WAS IMPLANTED TO SEAL THE LEAK. ON (B)(6) 2011, THE PHYSICIAN INSPECTED THE POSITIONING OF THE STENT BECAUSE "THE PATIENT GOT PROBLEMS." THE PATIENT COMPLICATIONS EXPERIENCED WERE NOT PROVIDED. AT THIS TIME, THE PHYSICIAN NOTED THAT MOST OF THE STENT COVERING APPEARED TO HAVE DISINTEGRATED. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS. UPON REMOVAL, THE PHYSICIAN NOTED THAT THE REMAINING STENT COVERING WAS GREEN DUE TO BILE IN THE STOMACH. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED SINCE (B)(4) 2011. THE PATIENT HAD EARLY ANASTOMOTIC INSUFFICIENCY FOLLOWING ORAL GASTRIC RESECTION DUE TO CARDIA CARCINOMA. PRIOR TO THE STENT PLACEMENT PROCEDURE, THE PATIENT HAD SEPTIC CONDITIONS AND GROWING INFECTION PARAMETERS. THE STENT WAS PLACED ON (B)(6) 2011. TEN DAYS FOLLOWING THE STENT PLACEMENT, THE COVERING OF THE STENT WAS NOTED TO BE COMPLETELY DESTROYED; THE MIDDLE PART OF THE STENT SHOWED LARGE SECTIONS WITHOUT COVERING. IN ADDITION, THE FISTULA WAS NOT TIGHTLY SEALED. AT THIS TIME, THE STENT WAS REMOVED AND NO COVER WAS PRESENT ON THE STENT. DUE TO THE SEPTIC CONDITIONS OF THE PATIENT AND THE STENT MALFUNCTION, THE PATIENT UNDERWENT A DISSECTION OF THE ANASTOMOSIS WITH COLLAR ESOPHAGOSTOMY ALONG WITH "CLOSURE OF THE GASTRIC REST ALS SALVAGE TREATMENT." IN THE PHYSICIAN'S ASSESSMENT, THIS INTERVENTION WAS PERFORMED AS A RESULT OF THE MALFUNCTION OF THE STENT; HOWEVER, THE INSUFFICIENCY MAY NOT HAVE BEEN RESOLVED EVEN WITH THE PROPER FUNCTIONING OF THE STENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2011. THE PHYSICIAN PLANS TO PERFORM A SECOND OPERATION IN SIX MONTHS TO PERFORM COLON SEGMENT INTERPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX COVERED ESOPHAGEAL STENT WAS IMPLANTED DURING A PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD AN ESOPHAGOGASTROSTOMY DUE TO AN ESOPHAGEAL MALIGNANCY. DURING THE SURGERY, A PORTION OF THE STOMACH WAS RESECTED. FOLLOWING THE SURGERY, A 4MM LEAK OCCURRED AT THE SITE OF THE ANASTOMOSIS. ON (B)(6), 2011, THE STENT WAS IMPLANTED TO SEAL THE LEAK. ON (B)(6), 2011, THE PHYSICIAN INSPECTED THE POSITIONING OF THE STENT BECAUSE "THE PATIENT GOT PROBLEMS." THE PATIENT COMPLICATIONS EXPERIENCED WERE NOT PROVIDED. AT THIS TIME, THE PHYSICIAN NOTED THAT MOST OF THE STENT COVERING APPEARED TO HAVE DISINTEGRATED. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS. UPON REMOVAL, THE PHYSICIAN NOTED THAT THE REMAINING STENT COVERING WAS GREEN DUE TO BILE IN THE STOMACH. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. **ADDITIONAL INFORMATION RECEIVED SINCE (B)(6), 2011** THE PATIENT HAD EARLY ANASTOMOTIC INSUFFICIENCY FOLLOWING ORAL GASTRIC RESECTION DUE TO CARDIA CARCINOMA. PRIOR TO THE STENT PLACEMENT PROCEDURE, THE PATIENT HAD SEPTIC CONDITIONS AND GROWING INFECTION PARAMETERS. THE STENT WAS PLACED ON (B)(6), 2011. TEN DAYS FOLLOWING THE STENT PLACEMENT, THE COVERING OF THE STENT WAS NOTED TO BE COMPLETELY DESTROYED; THE MIDDLE PART OF THE STENT SHOWED LARGE SECTIONS WITHOUT COVERING. IN ADDITION, THE FISTULA WAS NOT TIGHTLY SEALED. AT THIS TIME, THE STENT WAS REMOVED AND NO COVER WAS PRESENT ON THE STENT. DUE TO THE SEPTIC CONDITIONS OF THE PATIENT AND THE STENT MALFUNCTION, THE PATIENT UNDERWENT A DISSECTION OF THE ANASTOMOSIS WITH COLLAR ESOPHAGOSTOMY ALONG WITH "CLOSURE OF THE GASTRIC REST ALS SALVAGE TREATMENT." IN THE PHYSICIAN'S ASSESSMENT, THIS INTERVENTION WAS PERFORMED AS A RESULT OF THE MALFUNCTION OF THE STENT; HOWEVER, THE INSUFFICIENCY MAY NOT HAVE BEEN RESOLVED EVEN WITH THE PROPER FUNCTIONING OF THE STENT. THE PATIENT WAS DISCHARGED ON (B)(6), 2011. THE PHYSICIAN PLANS TO PERFORM A SECOND OPERATION IN SIX MONTHS TO PERFORM COLON SEGMENT INTERPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX COVERED ESOPHAGEAL STENT WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD AN ESOPHAGOGASTROTOMY DUE TO AN ESOPHAGEAL MALIGNANCY. DURING THE SURGERY, A PORTION OF THE STOMACH WAS RESECTED. FOLLOWING THE SURGERY, A 4MM LEAK OCCURRED AT THE SITE OF THE ANASTOMOSIS. ON (B)(6) 2011, THE STENT WAS IMPLANTED TO SEAL THE LEAK. ON (B)(6) 2011, THE PHYSICIAN INSPECTED THE POSITIONING OF THE STENT BECAUSE "THE PATIENT GOT PROBLEMS." THE PATIENT COMPLICATIONS EXPERIENCED WERE NOT PROVIDED. AT THIS TIME, THE PHYSICIAN NOTED THAT MOST OF THE STENT COVERING APPEARED TO HAVE DISINTEGRATED. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS. UPON REMOVAL, THE PHYSICIAN NOTED THAT THE REMAINING STENT COVERING WAS GREEN DUE TO BILE IN THE STOMACH. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX¿ ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00514200 14199961

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention