BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 3921626 · Received July 9, 2014

    Report

    Report Number
    2134265-2014-03890
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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; 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 DEPLOYMENT ISSUE AND SHORTENING OF STENT OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE NON CALCIFIED AND MILDLY TORTUOUS PROXIMAL LEFT CIRCUMFLEX ARTERY. AFTER A NON BSC GUIDE WIRE CROSS THE LESION, A 3.0MM X 12MM NON BSC BALLOON CATHETER WAS ADVANCED FOR PREDILATION OF THE LESION FOR 5 SECONDS AT 8 ATMOSPHERES. THEN THE 12MM X 3.50 MM PROMUS PREMIER STENT WAS ADVANCED TO THE LESION WITHOUT RESISTANCE. THE STENT DELIVERY SYSTEM (SDS) BALLOON WAS FIRST INFLATED FOR 15 SECONDS AT 10 ATMOSPHERES. ON THE SECOND INFLATION, THE STENT WAS DEPLOYED AT 11 ATMOSPHERES AND AN OPTICROSS IMAGING CATHETER WAS ADVANCED TO OBSERVE THE DILATED LESION. IT WAS NOTED THAT THE IMPLANTED STENT WAS NOT FULLY DILATED SO POST DILATION WAS DONE USING THE SDS BALLOON. THERE WAS NO RESISTANCE ENCOUNTERED DURING REMOVAL OF THE SDS. HOWEVER, IT WAS FOUND OUT THROUGH INTRAVASCULAR ULTRASOUND THAT THE LENGTH OF THE STENT WAS SHORTER THAN 1.3MM. THE STENT LENGTH WAS CHECKED BY COMPARING TO THE LENGTH OF BALLOON MARKER. THE IMPLANTED STENT COVERED THE LESION SO NO ADDITIONAL TREATMENT WAS PERFORMED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399093 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925112350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GUIDING CATHETER: LAUNCHER 6FREBU 3.75| BALLOON CATHETER: LIFESEAR 3.0-12| GUIDEWIRE: ASAHI SION BLUE| IMAGING CATHETER: OPTICROS