BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS (R) SD RENAL/BILIARY

    MDR report key: 2202897 · Received August 11, 2011

    Report

    Report Number
    2134265-2011-03456
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE PATIENT HAD PREVIOUS STENTS PLACED BILATERALLY IN THE RENAL ARTERIES. THE PATIENT PRESENTED WITH A 99% STENOSED, PROGRESSIVE LESION LOCATED DISTALLY TO THE PREVIOUSLY IMPLANTED STENT IN THE SEVERELY CALCIFIED LEFT RENAL ARTERY. A 6F MACH 1 GUIDE CATHETER WAS INSERTED AND ADVANCED. THIS 5.0X19X90CM EXPRESS SD STENT WAS SELECTED FOR TREATMENT AND ADVANCED WITHOUT PRE-DILATION. THE PHYSICIAN CROSSED THE PREVIOUSLY IMPLANTED STENT WITHOUT RESISTANCE, BUT WAS NOT ABLE TO CROSS THE LESION WITH THE EXPRESS SD STENT DELIVERY SYSTEM (SDS). THE DECISION WAS MADE TO REMOVE THE SDS AND PRE-DILATE THE LESION WITH A SMALLER BALLOON. DURING REMOVAL OF THE SDS, THE PHYSICIAN ENCOUNTERED SIGNIFICANT RESISTANCE WITHDRAWING FROM THE STENOSIS. AFTER THE SDS WAS REMOVED FROM THE GUIDE CATHETER, THE PHYSICIAN NOTED THE STENT HAD DISLODGED. ANGIOGRAPHY SHOWED THAT THE STENT REMAINED UNDEPLOYED IN THE STENOSIS. THE STENT WAS "NOT IN A BAD POSITION", THEREFORE, THE PHYSICIAN OPTED TO LEAVE IT THERE AND DOES NOT PLAN TO REINTERVENE. THE PROCEDURE WAS ENDED AT THIS POINT. NO FURTHER PATIENT COMPLICATIONS WERE 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 H74937912519900 13317745

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 6F LIMA MACH 1 GUIDE CATHETER