BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2863800 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07810
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 20, 2012
    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). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DISSECTION IS LISTED IN THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 3.0 X 33 MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED. THE XIENCE V STENT WAS IMPLANTED AT 8 ATMOSPHERES; HOWEVER, A PROXIMAL EDGE DISSECTION WAS OBSERVED. A NEW XIENCE V STENT WAS USED TO TREAT THE DISSECTION AND THE PATIENT WAS DISCHARGED IN STABLE CONDITION. 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
    1 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2012541

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention