BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX? ESOPHAGEAL NG

    MDR report key: 3233913 · Received July 18, 2013

    Report

    Report Number
    3005099803-2013-06626
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FOR THE REPORTED EVENT OF STENT REMOVED PARTIALLY DEPLOYED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT WAS PARTIALLY DEPLOYED BY APPROXIMATELY 115 MM. DURING ANALYSIS, IT WAS POSSIBLE TO RETRACT THE REMAINDER OF THE DEPLOYMENT SUTURE THREAD AND DEPLOY THE STENT WITHOUT ANY ISSUE. NO ISSUES WERE NOTED WITH THE DEPLOYED STENT OR THE SHAFT OF THE DEVICE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. THE INVESTIGATION CONCLUDED THAT THIS COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THEREFORE, THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS USED DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2013. THE LESION WAS 24-35 CM LOCATED IN THE MID ESOPHAGUS TO GASTROESOPHAGEAL JUNCTION. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS DUE TO A GASTROINTESTINAL (GI) MALIGNANCY. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. THE LESION WAS NOT DILATED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE STENT WAS REPORTEDLY NOT DEPLOYING PROPERLY AND GOT STUCK MIDWAY THROUGH DEPLOYMENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 AN ULTRAFLEX ESOPHAGEAL DISTAL RELEASE COVERED STENT WAS USED DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2013. THE LESION WAS 24-35 CM LOCATED IN THE MID ESOPHAGUS TO GASTROESOPHAGEAL JUNCTION. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS DUE TO A GASTROINTESTINAL (GI) MALIGNANCY. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. THE LESION WAS NOT DILATED PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE STENT WAS REPORTEDLY NOT DEPLOYING PROPERLY AND GOT STUCK MIDWAY THROUGH DEPLOYMENT. THE PARTIALLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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
    334844 ULTRAFLEX? ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513750 15576355

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR