BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX MONORAIL

    MDR report key: 2012184 · Received March 9, 2011

    Report

    Report Number
    2134265-2011-00798
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    July 1, 2010
    Report Date
    February 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT 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

    SAME PATIENT AS MFR#: 2134265-2011-00635. (B)(B). IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE BALLOON POSITIONING ISSUES OCCURRED. TARGET LESION 1 WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH WITH 90% STENOSIS AND WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X16MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. TARGET LESION 2 WAS LOCATED IN THE 2ND OBTUSE MARGINAL BRANCH WITH 90% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25X12MM TAXUS LIBERTE STENT. RESIDUAL STENOSIS WAS 0% TARGET LESION 3 WAS AN OSTIAL LESION LOCATED IN THE RIGHT CORONARY ARTERY WITH 70% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER 3.5MM. PRE-DILATATION WAS ATTEMPTED WITH THE 2.0X12MM APEX BALLOON HOWEVER IT WAS UNABLE TO CROSS THE LESION AND THE BALLOON KEPT SLIPPING. THE LESION WAS TREATED WITH PRE-DILATATION WITH A 3.0X12MM APEX BALLOON AND PLACEMENT OF A 3.00X12MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. SEVEN MONTHS POST PROCEDURE IN (B)(6) 2011 THE PATIENT PRESENTED FOR CARDIAC CATHETERIZATION FOR INDICATIONS OF UNSTABLE ANGINA WITH KNOWN CORONARY ARTERY DISEASE. THE RIGHT CORONARY ARTERY HAD 90% IN-STENT RESTENOSIS. THE PATIENT UNDER WENT A SUCCESSFUL CABG. THE LEFT INTERNAL THORACIC ARTERY TO THE DISTAL LEFT ANTERIOR DESCENDING ARTERY. SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL BRANCH, DIAGONAL BRANCH AND THE DISTAL RIGHT CORONARY ARTERY. THE PATIENT WAS DISCHARGED 7 DAYS LATER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX MONORAIL CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE H7493895912300

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR