BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA?

    MDR report key: 3232529 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04744
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    April 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF AN OMEGA STENT DELIVERY SYSTEM (SDS) AND STENT WITH NO ORIGINAL PACKAGING OR OTHER DEVICES. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURE ON THE BALLOON. THE DISTAL PORTION OF THE STENT HAD BENT, FLARED AND OVERLAPPING STRUTS THAT WERE STRETCHED PAST THE DISTAL MARKERBAND. THERE WERE MULTIPLE HYPOTUBE KINKS. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. 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

    REPORTABLE BASED ON ANALYSIS COMPLETED (B)(4) 2013. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY, A SHAFT BEND OCCURRED. VASCULAR ACCESS WAS GAINED VIA THE RADIAL ARTERY. THE 2.25X20MM, >90% STENOSED, ECCENTRIC AND PROGRESSIVE, TYPE C TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT CIRCUMFLEX (LCX) ARTERY. AS THE 2.25X20MM OMEGA STENT SYSTEM WAS ADVANCED TO THE TARGET LESION THE PHYSICIAN ENCOUNTERED RESISTANCE ADVANCING THE DEVICE AND THE SHAFT BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 2.25X20MM OMEGA STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD, HOWEVER RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336118 OMEGA? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913820220 15747626

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: .014 PT2