BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3852211 · Received June 5, 2014

    Report

    Report Number
    2024168-2014-03616
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PATIENT EFFECT OF DISSECTION IS A KNOWN POTENTIAL PATIENT EFFECT AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU). ALTHOUGH, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS HIGHLY CALCIFIED LESION AND LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). A WHISPER GUIDE WIRE WAS USED TO ACCESS THE LESION, AFTER WHICH PRE-DILATATION WAS PERFORMED WITH A MINI TREK BALLOON. THEN A XIENCE PRIME 2.75 X 15 MM STENT WAS DEPLOYED. POST STENT DEPLOYMENT, ANGIOGRAPHY REVEALED THAT THE PROXIMAL AND DISTAL EDGE OF THE STENT HAD DISSECTED THE ARTERY. A XIENCE PRIME 2.75 X 33 MM STENT WAS IMPLANTED TO COVER THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328750 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3121941

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention GUIDE WIRE: WHISPER