BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4111217 · Received September 23, 2014

    Report

    Report Number
    2024168-2014-06128
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    December 6, 2013
    Report Date
    August 29, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS, AS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF THE DEVICE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. THE 3.0X28MM XIENCE PRIME REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH STABLE ANGINA ON (B)(6) 2013. ON (B)(6) 2013 THE 2.25X28MM XIENCE PRIME STENT WAS DEPLOYED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE 3.0X28MM XIENCE PRIME STENT WAS DEPLOYED IN THE PROXIMAL LAD. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY REPORTED DEVICE OR PROCEDURE ISSUES. ON (B)(6) 2013 THE PATIENT PRESENTED TO THE HOSPITAL WITH ANGINA, AND ANGIOGRAM REVEALED IN-STENT RESTENOSIS, WHICH WAS TREATED WITH DEPLOYMENT OF A 3.5X26MM NON-ABBOTT STENT IMPLANT AND A 2.5X38MM XIENCE XPEDITION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND THE RESTENOSIS WAS RESOLVED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589780 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R 2.25X28MM XIENCE PRIME