BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS¿ LD VASCULAR

    MDR report key: 2832368 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-07065
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. AGE AT TIME OF EVENT 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE LEFT BRACHIAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS LEFT SUBCLAVIAN ARTERY. A NON BSC 6F SHEATH WAS INSERTED THEN A NON BSC 2MM BALLOON CATHETER AND A NON BSC GUIDE WIRE CROSSED THE LESION. IVUS WAS PERFORMED. PRE DILATION WAS PERFORMED USING A NON BSC 2MM BALLOON CATHETER THEN THE 7.0X20X75CM EXPRESS LD VASCULAR STENT ADVANCED AND BUMPED INTO THE OSTIUM OF THE LESION. THE EXPRESS STENT WAS WITHDRAWN AS THE PHYSICIAN WANTED TO PERFORM PRE DILATION. THE DISTAL EDGE OF THE STENT BECAME STUCK IN THE LESION AND THE STENT DISLODGED. IT WAS ATTEMPTED TO REMOVE THE DISLODGED STENT WITH A SNARE; HOWEVER, THE STENT WAS UNABLE TO BE CAPTURED AND PULLED BACK INTO THE 6F SHEATH. REMOVAL ATTEMPTS WERE SUSPENDED AND THE TARGET LESION WAS TREATED WITH PLACEMENT OF AN EXPRESS LD STENT. THE PHYSICIAN THEN SUCCESSFULLY REMOVED THE DISLODGED STENT SURGICALLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS¿ LD VASCULAR CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY H74938162720750 15250721

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDE WIRE: CRUISE 35 RADIFOCUS| BALLOON CATHETER: JACKAL, STERLING| INTRODUCER SHEATH: 6F PARENT