BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMEGA PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2223074 · Received August 25, 2011

    Report

    Report Number
    2134265-2011-03466
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE A STENT FRACTURE OCCURRED. THE LESION BEING TREATED WAS AN 80% STENOSIS OF THE MILDLY TORTUOUS, MILDLY CALCIFIED DISTAL RCA (RIGHT CORONARY ARTERY). THE LESION WAS PRE-DILATED WITH A 2.5X30MM MAVERICK2 BALLOON AT 12ATM. THE DISTAL SEGMENT OF THE RCA WAS STENTED WITH A 3.0X32MM OMEGA STENT DEPLOYED AT 14ATM AND POST DILATED WITH A 3.5X15MM QUANTUM MAVERICK BALLOON AT 16ATM. POST STENTING ANGIOGRAPHY SHOWED FRACTURES IN THE DISTAL PORTION OF THE STENT SO THE PHYSICIAN ADVANCED A 3.5X24MM OMEGA STENT, BUT ENCOUNTERED RESISTANCE. ANGIOGRAPHY SHOWED SHORTENING OF THE PROXIMAL PORTION OF THE IMPLANTED 3.0X32MM OMEGA STENT. THE 3.5X24MM OMEGA STENT DELIVERY SYSTEM WAS REMOVED AND ANOTHER MANUFACTURER'S 3.0X38MM STENT WAS ADVANCED TO COVER THE ENTIRE STENT. VASOSPASM OCCURRED AND WAS TREATED WITH NITROGLYCERINE BUT EVIDENCE OF STENOSIS IN THE PROXIMAL PORTION OF THE STENT WAS NOTED. THE SAME 3.5X24MM OMEGA STENT WAS PLACED TO COVER THE AREA OF STENT SHORTENING AND THE EVENT WAS RESOLVED. THE PHYSICIAN FELT THAT THE DAMAGE TO THE 3.0X32MM OMEGA STENT WAS CAUSED BY THE QUANTUM MAVERICK BALLOON. 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
    1 OMEGA PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913832300 14278718

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention