BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM

    MDR report key: 1640156 · Received March 25, 2010

    Report

    Report Number
    2134265-2010-01500
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    February 24, 2010
    Report Date
    February 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIO
    PMA / PMN Number
    P090003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT CONSISTED OF THE STENT DELIVERY SYSTEM, WITHOUT THE STENT. VISUAL EXAMINATION OF THE BALLOON MATERIAL NOTED THAT IT WAS CORRECTLY FOLDED AND WRAPPED. THERE WAS EVIDENCE OF CRIMP MARKS ALONG THE BALLOON MATERIAL. A TACTILE EXAMINATION OF THE SHAFT OF THE DELIVERY SYSTEM NOTED A KINK APPROXIMATELY 10MM DISTAL TO THE STRAIN RELIEF. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED USER RELATED AS THE DEVICE WAS NOT USED IN ACCORDANCE WITH THE DFU. THE DEVICE IS INDICATED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE; HOWEVER, THE INTENDED USE OF THE DEVICE WAS IN THE SUPERFICIAL FEMORAL ARTERY (SFA). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING PROCEDURE, A STENT DISLODGEMENT OCCURRED.THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 7.0X30X135CM EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM WAS ADVANCED INTO THE PATIENT OVER A NON BSC GLIDE WIRE. THE STENT BECAME DISLODGED FROM ITS DELIVERY SYSTEM IN THE ILIAC ARTERY AFTER GETTING CAUGHT ON A BIFURCATION. THE PHYSICIAN OPTED TO DEPLOY THE STENT IN THE ILIAC ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT¿S CONDITION IS REPORTED AS ¿OK¿.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING PROCEDURE, A STENT DISLODGEMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE 7.0X30X135CM EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM WAS ADVANCED INTO THE PATIENT OVER A NON BSC GLIDE WIRE. THE STENT BECAME DISLODGED FROM ITS DELIVERY SYSTEM IN THE ILIAC ARTERY AFTER GETTING CAUGHT ON A BIFURCATION. THE PHYSICIAN OPTED TO DEPLOY THE STENT IN THE ILIAC ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO ADDITIONAL PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S CONDITION IS REPORTED AS `OK'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS LD ILIAC/BILIARY PREMOUNTED STENT SYSTEM STENT, ILIAC NIO BOSTON SCIENTIFIC - GALWAY H74938047730130 12707449

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other| R ST. JUDE GLIDE WIRE 260| 6F COOK RAABE SHEATH