BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMEGA¿

    MDR report key: 2831273 · Received November 14, 2012

    Report

    Report Number
    2134265-2012-06882
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THERE WAS CONTRAST IN THE INFLATION LUMEN. THE STENT WAS CENTERED BETWEEN THE MARKERBANDS ON THE TIGHTLY FOLDED BALLOON; THERE WAS NO INDICATION THE DEVICE WAS SUBJECTED TO POSITIVE (INFLATION) PRESSURE. THERE WERE MULTIPLE STENT STRUTS STRETCHED AND BENT IN THE FIRST AND FOURTH THROUGH SIXTH DISTAL STENT ROWS. MAGNIFIED INSPECTION PRESENTED NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE STENT DAMAGE. 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 AND/OR PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 4.5X20MM, ECCENTRIC SHAPED, 80% STENOTIC, DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 4.5X15MM QUANTUM MAVERICK BALLOON. THE PHYSICIAN FIRST DEPLOYED A 4.5X20M OMEGA STENT IN THE DISTAL RCA. THE PHYSICIAN THEN INTRODUCED A 4.5X24MM OMEGA STENT INTO THE TARGET LESION AND DURING IMAGING OBSERVED THAT THE DEVICE LOOKED UNUSUAL. UPON REMOVAL, IT WAS OBSERVED THAT THE STENT HAD MOVED FORWARD, AND IT'S STRUCTURE WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.5X20MM OMEGA STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS DEVICE IS ONLY OUS APPROVED BUT IS SIMILAR TO MARKETED US DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. ACCESS WAS OBTAINED THROUGH THE FEMORAL ARTERY. THE 4.5X20MM, ECCENTRIC SHAPED, 80% STENOTIC, DE NOVO LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 4.5X15MM QUANTUM MAVERICK BALLOON. THE PHYSICIAN FIRST DEPLOYED A 4.5X20M OMEGA STENT IN THE DISTAL RCA. THE PHYSICIAN THEN INTRODUCED A 4.5X24MM OMEGA STENT INTO THE TARGET LESION AND DURING IMAGING OBSERVED THAT THE DEVICE LOOKED UNUSUAL. UPON REMOVAL IT WAS OBSERVED THAT THE STENT HAD MOVED FORWARD AND ITS STRUCTURE WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH ANOTHER 4.5X20MM OMEGA STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE. THIS DEVICE IS ONLY OUS APPROVED BUT IS SIMILAR TO MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493913824450 15279250

    Patients

    Seq Age Sex Outcome Treatment
    1 4.5X20MM OMEGA STENT| 4.5X8MM QUANTUM BALLOON CATHETER| MACH1 GUIDE CATHTER 6F, JR4 6F