BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2231781 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06095
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    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. STENT: 2.5 X 23 MM XIENCE V. OTHER: ASPIRIN 81 MG, CLOPIDOGREL 75 MG. THE ADDITIONAL 2.5 X 23 MM XIENCE V (B)(6) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ISCHEMIA AND RE-STENOSIS ARE LISTED IN THE JAPAN XIENCE V INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IT SHOULD BE NOTED THAT THE JAPAN IFU STATES THAT THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUALT TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 3.75MM. IT IS NOT LIKELY THAT THE REPORTED IFU DEVIATION(S) CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECT(S) THAT OCCURRED AFTER THE INDEX PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY EIGHT MONTHS POST XIENCE V STENTING PROCEDURE IN A 40 MM LONG LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH TWO OVERLAPPING 2.5 X 23 MM STENTS, THE PATIENT EXPERIENCED SILENT ISCHEMIA. ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ON (B)(6) 2011 UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION FOR RESTENOSIS IN THE INDEX TARGET LESION. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2011. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0062141

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R