BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF

    MDR report key: 1934783 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05322
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-SURGICAL MEDICAL INTERVENTION REQUIRED. (B)(4) STENT PARTIALLY DEPLOYED. 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.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE PRESENTED WITH THE DISTAL END DEPLOYED BY ABOUT 5MM. THE DELIVERY SYSTEM WAS CURVED TOWARDS THE DISTAL END. NO ISSUES WERE NOTED WITH THE CROCHET STITCHES AT THE POINT OF RELEASE FROM THE STENT. DURING A FUNCTIONAL ANALYSIS, IT WAS POSSIBLE TO FULLY DEPLOY THE STENT WITHOUT ISSUE. THE CONDITION OF THE RETURNED DEVICE IS CONSISTENT WITH THE REPORTED EVENT. THE MOST PROBABLE ROOT CAUSE OF THE COMPLAINT EVENT IS BEING ATTRIBUTED TO OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A LABELING REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX UNCOVERED TRACHEOBRONCHIAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE LEFT BRONCHUS ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A MALIGNANT TUMOR DEEP WITHIN THE BRONCHUS. AFTER APPROXIMATELY ONE-THIRD OF THE STENT HAD DEPLOYED, THE SUTURE GOT HUNG UP. THE PHYSICIAN PULLED WITH MORE FORCE, BUT COULD NOT GET THE STENT TO DEPLOY; THE DELIVERY SYSTEM CONTINUED TO BOW AS HE PULLED, AND THE STENT WOULD NOT FURTHER DEPLOY. THE PHYSICIAN ADDED THAT THIS TUMOR WAS PARTICULARLY VASCULAR, AND THAT WHEN THE PARTIALLY DEPLOYED STENT WAS PULLED OUT, THE TUMOR WAS CUT, WHICH CAUSED A BLEED. THE PHYSICIAN HAD TO EXCHANGE OUT THE DEVICE AND PLACE ANOTHER ULTRAFLEX STENT WITHIN THE PATIENT. THE PHYSICIAN ALSO HAD TO USE A FORM OF CRYOSPRAY ABLATION THERARPY TO IN ORDER TO STOP THE BLEED. THE PATIENT IS CURRENTLY IN STABLE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX UNCOVERED TRACHEOBRONCHIAL STENT WAS USED DURING A STENTING PROCEDURE WITHIN THE LEFT BRONCHUS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH A MALIGNANT TUMOR DEEP WITHIN THE BRONCHUS. AFTER APPROXIMATELY ONE-THIRD OF THE STENT HAD DEPLOYED, THE SUTURE GOT HUNG UP. THE PHYSICIAN PULLED WITH MORE FORCE, BUT COULD NOT GET THE STENT TO DEPLOY; THE DELIVERY SYSTEM CONTINUED TO BOW AS HE PULLED, AND THE STENT WOULD NOT FURTHER DEPLOY. THE PHYSICIAN ADDED THAT THIS TUMOR WAS PARTICULARLY VASCULAR, AND THAT WHEN THE PARTIALLY DEPLOYED STENT WAS PULLED OUT, THE TUMOR WAS CUT, WHICH CAUSED A BLEED. THE PHYSICIAN HAD TO EXCHANGE OUT THE DEVICE AND PLACE ANOTHER ULTRAFLEX STENT WITHIN THE PATIENT. THE PHYSICIAN ALSO HAD TO USE A FORM OF CRYOSPRAY ABLATION THERARPY TO IN ORDER TO STOP THE BLEED. THE PATIENT IS CURRENTLY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAF PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00564520 13139044

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention