BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS (R) LD ILIAC / BILIARY

    MDR report key: 2213490 · Received August 16, 2011

    Report

    Report Number
    2134265-2011-03536
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 21, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, BALLOON REMOVAL DIFFICULTIES AND STENT MOVEMENT OCCURRED. THE LESIONS BEING TREATED WERE LOCATED BILATERALLY IN THE ILIAC ARTERIES. FOLLOWING ADVANCEMENT OF NON-BSC 7 X 25 CM SHEATHS, EXPRESS BILIARY STENT DELIVERY SYSTEMS WERE ADVANCED AND BOTH SIDES WERE DEPLOYED AT THE SAME TIME (KISSING STENT TECHNIQUE). ON THE LEFT THE 10.0 X 60MM EXPRESS BILIARY STENT BALLOON WAS DILATED TO NOMINAL. WHEN THE PHYSICIAN DEFLATED THE BALLOON AND ATTEMPTED TO REMOVE IT, THE BALLOON GOT STUCK IN THE STENT. THE PHYSICIAN REINFLATED THE BALLOON TO 4 ATM THEN DEFLATED AGAIN. WITH SOME EFFORT HE WAS ABLE TO PULL THE BALLOON OUT. THE STENT ENDED UP 1-2 MM BELOW WHERE IT HAD ORIGINALLY BEEN PLACED. NO FURTHER INTERVENTION WAS REQUIRED. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS LISTED AS FINE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE STENT WAS DEPLOYED AT NOMINAL PRESSURE WITH ONE INFLATION. THE STENT WAS FULLY DEPLOYED WITH THE BALLOON FULLY INFLATED AT 10 ATMS. THERE SEEMED TO BE NO WAIST AND NO DIFFICULTY DEPLOYING. NO DAMAGE WAS NOTED TO THE BALLOON UPON REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS (R) LD ILIAC / BILIARY STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938047160130 13229236

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other