BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 4200469 · Received October 24, 2014

    Report

    Report Number
    2024168-2014-06981
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. INTIMAL DISSECTION IS LISTED IN THE XIENCE PRO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE ELECTRONIC LOT HISTORY RECORD (ELHR) WAS REVIEWED FOR THE REPORTED LOT AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE XIENCE PRO IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US. THE PRODUCT CODE LISTED AND THE PMA# LISTED IS BASED ON THE PREDICATE DEVICE (XIENCE V) AND IS THEREFORE SIMILAR TO A DEVICE SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED, HEAVILY TORTUOUS, MID CIRCUMFLEX CORONARY ARTERY PROCEDURE, DURING USE OF THE 2.5 X 28 MM XIENCE PRO A DISSECTION OCCURRED. ANOTHER NON-SPECIFIED STENT WAS USED TO COVER THE DISSECTION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678767 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3080941

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention