BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WALLSTENT? BILIARY

    MDR report key: 3181336 · Received June 21, 2013

    Report

    Report Number
    3005099803-2013-05259
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K012752
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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 OUTER SHEATH HAD BEEN FULLY RETRACTED AND THE STENT WAS FULLY DEPLOYED AND RETURNED. THERE WERE NO ISSUES NOTED TO THE MOVEMENT OF THE OUTER SHEATH PROXIMALLY OR DISTALLY. THERE WERE NO ISSUES NOTED TO THE STENT OR DELIVERY SYSTEM. BASED ON THE CONDITION OF THE RETURNED DEVICE, THE REPORTED FAILURE COULD NOT BE CONFIRMED. HOWEVER, IT IS LIKELY THAT THE DIFFICULTIES EXPERIENCED DURING DEPLOYMENT WERE DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE 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 A WALLSTENT BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE WITH STENT IMPLANTATION PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT ICTERUS (JAUNDICE) AND EPIGASTRIC PAIN DUE TO A 3 CM STRICTURE IN THE MIDDLE COMMON BILE DUCT. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. THE LESION WAS DILATED TO 8MM USING A BALLOON PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE BILE DUCT AND THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE PHYSICIAN COULD NOT COMPLETELY DEPLOY THE STENT AND THE STENT COULD NOT BE RECONSTRAINED. WHEN THE PARTIALLY DEPLOYED STENT WAS BEING REMOVED FROM THE PATIENT, THE STENT ACCIDENTALLY DEPLOYED. THE FULLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. 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 A WALLSTENT BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE WITH STENT IMPLANTATION PERFORMED ON (B)(4) 2013. ACCORDING TO THE COMPLAINANT, THE INDICATION FOR STENT PLACEMENT WAS TO TREAT ICTERUS (JAUNDICE) AND EPIGASTRIC PAIN DUE TO A 3 CM STRICTURE IN THE MIDDLE COMMON BILE DUCT. THE PATIENT'S ANATOMY WAS NOT TORTUROUS. THE LESION WAS DILATED TO 8MM USING A BALLOON PRIOR TO THE PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS ADVANCED INTO THE BILE DUCT AND THE PHYSICIAN ATTEMPTED TO DEPLOY THE STENT. THE PHYSICIAN COULD NOT COMPLETELY DEPLOY THE STENT AND THE STENT COULD NOT BE RECONSTRAINED. WHEN THE PARTIALLY DEPLOYED STENT WAS BEING REMOVED FROM THE PATIENT, THE STENT ACCIDENTALLY DEPLOYED. THE FULLY DEPLOYED STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLSTENT BILIARY STENT. 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
    282031 WALLSTENT? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H965430500 14899488

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention