BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER?

    MDR report key: 3955215 · Received July 24, 2014

    Report

    Report Number
    2134265-2014-04242
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 40% STENOSED TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT CORONARY ARTERY (RCA). A 2.50X20MM AND A 3.00X20MM PREMIER STENTS WERE FIRST IMPLANTED IN THE DISTAL RCA. SUBSEQUENTLY, A 32 X 3.50 PROMUS PREMIER¿ DRUG ELUTING STENT WAS SELECTED FOR USE TO TREAT THE MID RCA LESION. HOWEVER, THE PHYSICIAN "STRUGGLED" TO DELIVER THE DEVICE BUT IT MIGHT HAVE BEEN CAUGHT ON CALCIUM OR WAS BUMPED BY THE GUIDE CATHETER WHICH MAY HAVE CAUSED THE PROXIMAL SEGMENT OF THE STENT TO FLARE/ EXPAND. THE PHYSICIAN ADDED THAT HE WAS DEEP THROATING THE STENT DELIVERY SYSTEM TO HELP DELIVER THE STENT WHICH MAY HAVE ALSO CAUSED THE AXIAL LENGTH TO CHANGE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DAMAGED STENT THROUGH THE 6F UNSPECIFIED CATHETER BUT FAILED AS THE STENT WAS ALREADY BIGGER THAN THE INTERNAL DIAMETER OF THE CATHETER AND COULDN'T FIT BACK THROUGH THE GUIDE CATHETER. EVENTUALLY, THE STENT WAS RETRIEVED BY USING A SNARING DEVICE. USED FEMORAL APPROACH TO DELIVER A NEW 32 X 3.50 PROMUS PREMIER¿ DRUG ELUTING STENT TO TREAT THE MID RCA LESION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434172 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925132350 16907192

    Patients

    Seq Age Sex Outcome Treatment
    1 PREMIER 3.00X20MM STENT| PREMIER 2.50X20MM STENT