BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX MONORAIL

    MDR report key: 1163560 · Received September 17, 2008

    Report

    Report Number
    2134265-2008-02696
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LOX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTIONAL PROCEDURE, A SHAFT BREAK OCCURRED. THE LESION WAS LOCATED IN THE MODERATELY TORTUOUS POSTEROLATERAL BRANCH OF DISTAL LEFT CIRCUMFLEX (LCX). ANOTHER MANUFACTURER'S 2.5-18MM STENT WAS DEPLOYED FROM THE DISTAL TO POSTERIOR DESCENDING BRANCH OF LCX. THEN THE OSTIUM OF POSTEROLATERAL BRANCH WAS OCCLUDED DUE TO PLAQUE SHIFT. THE APEX 2.5-15MM BALLOON WAS DILATED IN THE POSTEROLATERAL BRANCH VIA A STENT STRUT. AND THEN THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS DELIVERED IN LCX FOR KISSING BALLOON TECHNIQUE HOWEVER THE SDS BALLOON WAS NOT ABLE TO CROSS THERE. THE APEX BALLOON WAS REMOVED OUTSIDE THE PATIENT'S BODY WITHOUT RESISTANCE, HOWEVER THE PHYSICIAN HAD NOTED THAT THE DISTAL SHAFT HAD SEPARATED. THE SEPARATED SHAFT REMAINED IN THE POSTEROLATERAL BRANCH. THE PHYSICIAN ENGAGED THE MACH1 8F FL3.5 GUIDE CATHETER AND ATTEMPTED TO RETRIEVE THE SEPARATED SHAFT BY SNARE HOWEVER THE SHAFT WAS UNABLE TO BE RETRIEVED. THE FOLLOWING DAY THE REMAINING SHAFT FRAGMENT WAS RETRIEVED WITH A SNARE UNDER ECHO GUIDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL NA LOX BOSTON SCIENTIFIC 2.5X15MM 11321866

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AND RUNTHROUGH GUIDEWIRE (TERUMO)| LAUNCHER 6F AL1 (MEDTRONIC)| CYPHER 2.5-18MM STENT