BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX¿ ESOPHAGEAL NG

    MDR report key: 3012775 · Received March 20, 2013

    Report

    Report Number
    3005099803-2013-01655
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    ESW
    PMA / PMN Number
    K091816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. 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 HAD BEEN DEPLOYED FROM THE DEVICE AND HAD BEEN RETURNED. NO ISSUES WERE NOTED WITH THE DEPLOYED STENT. IT WAS NOTED THAT THE SHAFT WAS KINKED AT APPROXIMATELY 320 MM PROXIMAL TO THE DISTAL TIP. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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. 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 COMPLAINT IS ASSOCIATED WITH A PRODUCT THAT MEETS THE DESIGN AND MANUFACTURE SPECIFICATIONS BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, PERFORMANCE OF THE DEVICE WAS LIMITED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED ON (B)(6) 2013, DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT A MALIGNANT LOWER ESOPHAGEAL STRICTURE THAT HAD METASTASIZED FROM LUNG CANCER. REPORTEDLY, THE PATIENT'S LOWER ESOPHAGUS WAS OCCLUDED. THE LESION WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE PATIENT'S ANATOMY WAS REPORTED TO BE TORTUOUS. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE INTENDED LOCATION AND THE ENDOSCOPE WAS THEN REMOVED. THE PINK INJECTION NEEDLES WERE USED FOR PLACEMENT GUIDANCE, AND WERE AT THE PROXIMAL AND DISTAL PART OF STRICTURE. THEN, THE ULTRAFLEX ESOPHAGEAL STENT WAS INSERTED ALONG THE GUIDEWIRE. AFTER THE ULTRAFLEX ESOPHAGEAL STENT WAS ADVANCED INTO THE INTENDED POSITION, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT BY PULLING THE SUTURE OF THE STENT. WHEN THE SUTURE WAS PULLED NEAR THE STRICTURE, THE DELIVERY SYSTEM SHIFTED TO THE PROXIMAL SIDE. THEN, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT WHILE PUSHING THE DELIVERY SYSTEM, BUT THE STENT STARTED TO DEPLOY. THE PARTIALLY DEPLOYED STENT WAS REMOVED AND THE PROCEDURE WAS CLOSED. THE PHYSICIAN THEN OPTED FOR A PEG PLACEMENT PROCEDURE INSTEAD OF STENT PLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE STENT PLACEMENT PROCEDURE WAS REPORTED TO BE GOOD. ADDITIONAL FOLLOW-UP STATED THAT A PEG PROCEDURE WAS NOT PERFORMED DUE TO THE PATIENT'S PRIMARY ILLNESS (TERMINAL CANCER).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED ON (B)(6) 2013 DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT A MALIGNANT LOWER ESOPHAGEAL STRICTURE THAT HAD METASTASIZED FROM LUNG CANCER. REPORTEDLY, THE PATIENT'S LOWER ESOPHAGUS WAS OCCLUDED. THE LESION WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE PATIENT'S ANATOMY WAS REPORTED TO BE TORTUOUS. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE INTENDED LOCATION AND THE ENDOSCOPE WAS THEN REMOVED. THESE PINK INJECTION NEEDLES WERE USED FOR PLACEMENT GUIDANCE, AND WERE AT THE PROXIMAL AND DISTAL PART OF STRICTURE. THEN, THE ULTRAFLEX ESOPHAGEAL STENT WAS INSERTED ALONG THE GUIDEWIRE. AFTER THE ULTRAFLEX ESOPHAGEAL STENT WAS ADVANCED INTO THE INTENDED POSITION, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT BY PULLING THE SUTURE OF THE STENT. WHEN THE SUTURE WAS PULLED NEAR THE STRICTURE, THE DELIVERY SYSTEM SHIFTED TO THE PROXIMAL SIDE. THEN, THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT WHILE PUSHING THE DELIVERY SYSTEM, BUT THE STENT STARTED TO DEPLOY. THE PARTIALLY DEPLOYED STENT WAS REMOVED AND THE PROCEDURE WAS CLOSED. THE PHYSICIAN THEN OPTED FOR A PEG PLACEMENT PROCEDURE INSTEAD OF STENT PLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE STENT PLACEMENT PROCEDURE WAS REPORTED TO BE GOOD. ADDITIONAL FOLLOW-UP STATED THAT A PEG PROCEDURE WAS NOT PERFORMED DUE TO THE PATIENT'S PRIMARY ILLNESS (TERMINAL CANCER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116696 ULTRAFLEX¿ ESOPHAGEAL NG PROSTHESIS, ESOPHAGEAL ESW BOSTON SCIENTIFIC - GALWAY M00513860 15360659

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR