BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2897133 · Received January 4, 2013

    Report

    Report Number
    2024168-2013-00071
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    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 WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECT OF THROMBOSIS IS LISTED IN THE (B)(4) XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. 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 ON (B)(6) 2012, DUE TO UNSTABLE ANGINA, THE PATIENT UNDERWENT ANGIOGRAPHY, WHICH REVEALED A LESION AT THE LEFT MAIN AND PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 90% STENOSIS. A 3.5 X 33 MM XIENCE PRIME STENT WAS IMPLANTED AT 12 ATMOSPHERES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. ON (B)(6) 2012, THE PATIENT RETURNED AND THROMBOSIS WAS OBSERVED INSIDE THE XIENCE PRIME STENT. TREATMENT FOR THE THROMBOSIS WAS PERFORMED WITH AN ASPIRATION CATHETER AND BALLOONING. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5390 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 110274Q

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R