BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX

    MDR report key: 1834490 · Received September 15, 2010

    Report

    Report Number
    3005099803-2010-03944
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K955347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT DISTAL STENT LOOPS HAD BEEN DEPLOYED. NO OTHER ISSUES WERE NOTED WITH THE PROFILE OF THE DEVICE. FUNCTIONALLY, AN ATTEMPT WAS MADE TO DEPLOY THE STENT; HOWEVER, A RESISTANCE WAS NOTED AND THE STENT COULD NOT BE DEPLOYED. ADDITIONAL FORCE WAS REQUIRED IN ORDER TO GET THE STENT TO DEPLOY. NO ISSUES WERE IDENTIFIED WHICH COULD HAVE CONTRIBUTED TO THE INITIAL DIFFICULTIES. THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE COMPLAINT EVENT OF A PARTIALLY DEPLOYED STENT. THE MOST PROBABLE ROOT CAUSE HAS BEEN LABELED AS A DESIGN. 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 NO DEVIATION WAS FOUND.

    Additional Manufacturer Narrative · 1

    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 APPROXIMATELY ONE YEAR AGO (EXACT DATE UNKNOWN) AN ULTRAFLEX ESOPHAGEAL STENT (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-03938) WAS IMPLANTED TO TREAT A 3CM MALIGNANT STRICTURE IN THE ESOPHAGUS. APPROXIMATELY ONE YEAR AFTER BEING IMPLANTED (EXACT DATE UNKNOWN), IT WAS NOTED THAT THE STENT HAD BECOME OCCLUDED WITH TISSUE INGROWTH. ON (B)(6), 2010, IN AN EFFORT TO TREAT THE OCCLUSION, THE PHYSICIAN ATTEMPTED TO DEPLOY AN ULTRAFLEX ESOPHAGEAL COVERED STENT (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-03944) WITHIN THE OCCLUDED STENT. THE ANATOMY OF THE PATIENT WAS NOTED TO BE MODERATELY TORTUOUS, BUT PREDILATION WAS NOT PERFORMED. DURING THE ATTEMPTED DEPLOYMENT, THE PHYSICIAN FELT RESISTANCE WHILE PULLING ON THE DEPLOYMENT SUTURE AND THE STENT COULD ONLY BE DEPLOYED A FEW MILLIMETERS. THERE WAS NO NOTED BOWING OF THE DELIVERY SYSTEM. THE PHYSICIAN REMOVED THE DEVICE WITHOUT ISSUE AND NOTED THAT THE SUTURE HAD ENTANGLED AROUND THE STENT. TWO ADDITIONAL ULTRAFLEX COVERED STENTS AND THE SAME GUIDEWIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE ORIGINAL STENT REMAINS IMPLANTED. 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT APPROXIMATELY ONE YEAR AGO (EXACT DATE UNKNOWN) AN ULTRAFLEX ESOPHAGEAL STENT (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-03938) WAS IMPLANTED TO TREAT A 3CM MALIGNANT STRICTURE IN THE ESOPHAGUS. APPROXIMATELY ONE YEAR AFTER BEING IMPLANTED (EXACT DATE UNKNOWN), IT WAS NOTED THAT THE STENT HAD BECOME OCCLUDED WITH TISSUE INGROWTH. ON (B)(6), 2010, IN AN EFFORT TO TREAT THE OCCLUSION, THE PHYSICIAN ATTEMPTED TO DEPLOY AN ULTRAFLEX ESOPHAGEAL COVERED STENT (THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-03944) WITHIN THE OCCLUDED STENT. THE ANATOMY OF THE PATIENT WAS NOTED TO BE MODERATELY TORTUOUS, BUT PREDILATION WAS NOT PERFORMED. DURING THE ATTEMPTED DEPLOYMENT, THE PHYSICIAN FELT RESISTANCE WHILE PULLING ON THE DEPLOYMENT SUTURE AND THE STENT COULD ONLY BE DEPLOYED A FEW MILLIMETERS. THERE WAS NO NOTED BOWING OF THE DELIVERY SYSTEM. THE PHYSICIAN REMOVED THE DEVICE WITHOUT ISSUE AND NOTED THAT THE SUTURE HAD ENTANGLED AROUND THE STENT. TWO ADDITIONAL ULTRAFLEX COVERED STENTS AND THE SAME GUIDEWIRE WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE ORIGINAL STENT REMAINS IMPLANTED. 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 GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513150 13116875

    Patients

    Seq Age Sex Outcome Treatment
    1 JAGWIRE