BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 4141095 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06425
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 9, 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. THE STENT REMAINS IN THE VESSEL. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION, AS LISTED IN THE XIENCE PRO EVEROLIMUS ELUTING CORONARY STENT SYSTEM EXPANDED INDICATIONS INSTRUCTIONS FOR USE (IFU), IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. 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 XIENCE PRO IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US. THE PRODUCT CODE AND THE PMA IS BASED ON THE PREDICATE DEVICE (XIENCE V) AND IS THEREFORE SIMILAR TO A DEVICE SOLD IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE MILDLY CALCIFIED, MILDLY TORTUOUS, DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY DURING AN ANGIOPLASTY TO APPOSE THE 3.0 X 28 MM XIENCE PRO STENT A STENT EDGE DISSECTION OCCURRED. A SECOND UNSPECIFIED STENT WAS USED AS TREATMENT AND TO COMPLETE THE PROCEDURE WITHOUT REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618316 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4041641

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention