BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS (R) SD RENAL/BILIARY

    MDR report key: 2211464 · Received August 15, 2011

    Report

    Report Number
    2134265-2011-03533
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    FGE
    PMA / PMN Number
    K040027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED ONLY THE STENT DELIVERY SYSTEM WAS RECEIVED. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON, CENTERED BETWEEN THE MARKERBANDS, INDICATING THE STENT WAS APPROPRIATELY POSITIONED AND SECURED DURING MANUFACTURING. THE TIP WAS FLARED AND STRETCHED. FURTHER INSPECTION PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED WITHIN AND DISTAL TO A PREVIOUSLY PLACED UNKNOWN STENT IN THE CELIAC ARTERY. PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. IT WAS THE PHYSICIAN'S INTENTION TO DEPLOY THE 7.0X19MM EXPRESS SD RENAL/BILIARY STENT OVERLAPPING THE PREVIOUSLY IMPLANTED STENT DISTALLY. THE PHYSICIAN HAD ADVANCED THE EXPRESS DISTAL TO THE INTENDED LOCATION AND WHILE PULLING BACK TO REPOSITION, THE EXPRESS STENT DISLODGED FROM THE DELIVERY SYSTEM; HOWEVER, IT REMAINED ON THE GUIDE WIRE. IT WAS NOTED THAT THE EXPRESS STENT HAD POSSIBLY CAUGHT ON THE DISTAL EDGE OF THE PREVIOUSLY IMPLANTED STENT. A SNARING DEVICE WAS INSERTED AND THEY WERE ABLE TO BRING THE STENT BACK TO THE ILIAC ARTERY, BUT WERE UNABLE TO GET IT INTO THE SHEATH. THE STENT WAS TRAPPED AGAINST THE VESSEL WALL OF THE ILIAC ARTERY WITH A NON BSC COVERED STENT. THE PROCEDURE WAS ENDED AT THIS POINT AND TREATMENT OF THE ORIGINAL TARGET LESION WILL BE RESCHEDULED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED WITHIN AND DISTAL TO A PREVIOUSLY PLACED UNKNOWN STENT IN THE CELIAC ARTERY. PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON. IT WAS THE PHYSICIAN¿S INTENTION TO DEPLOY THE 7.0X19MM EXPRESS SD RENAL/BILIARY STENT OVERLAPPING THE PREVIOUSLY IMPLANTED STENT DISTALLY. THE PHYSICIAN HAD ADVANCED THE EXPRESS DISTAL TO THE INTENDED LOCATION AND WHILE PULLING BACK TO REPOSITION, THE EXPRESS STENT DISLODGED FROM THE DELIVERY SYSTEM; HOWEVER, IT REMAINED ON THE GUIDE WIRE. IT WAS NOTED THAT THE EXPRESS STENT HAD POSSIBLY CAUGHT ON THE DISTAL EDGE OF THE PREVIOUSLY IMPLANTED STENT. A SNARING DEVICE WAS INSERTED AND THEY WERE ABLE TO BRING THE STENT BACK TO THE ILIAC ARTERY, BUT WERE UNABLE TO GET IT INTO THE SHEATH. THE STENT WAS TRAPPED AGAINST THE VESSEL WALL OF THE ILIAC ARTERY WITH A NON BSC COVERED STENT. THE PROCEDURE WAS ENDED AT THIS POINT AND TREATMENT OF THE ORIGINAL TARGET LESION WILL BE RESCHEDULED. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS (R) SD RENAL/BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - MAPLE GROVE H74937912719150 13154346

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention