BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3182818 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03868
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 27, 2013
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IN THIS CASE, THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM 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 DEVICE IF ANY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE ADDITIONAL XIENCE PRIME REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID CIRCUMFLEX ARTERY WITH HEAVY TORTUOSITY, HEAVY CALCIFICATION AND 100% STENOSIS. PRE-DILATATION WAS PERFORMED. DURING IMPLANTATION OF THE XIENCE PRIME 2.5 X 8 MM STENT, A DISSECTION OCCURRED. HENCE A XIENCE PRIME 2.5 X 15 MM STENT WAS IMPLANTED TO COVER THE DISSECTION. HOWEVER THIS CAUSED FURTHER DISSECTION. A NON-ABBOTT STENT WAS IMPLANTED TO COVER THE DISSECTION. NO ADVERSE PATIENT SEQUELA WAS REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283684 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2032241

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention GUIDE WIRE: BMW, BHW