BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1920306 · Received December 10, 2010

    Report

    Report Number
    2024168-2010-02668
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    September 3, 2010
    Report Date
    November 16, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. (B)(4) NO PREDILATATION/INCORRECT ANATOMY. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RE-STENOSIS ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. IT WAS REPORTED THAT THE XIENCE V STENT WAS DIRECT STENTED (IMPLANTED WITH NO PRE-DILATATION) IN THE RE-STENOSED RIGHT CORONARY ARTERY (RCA). IT SHOULD BE NOTED THAT THE IFU STATES TO PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. THE IFU ALSO STATES THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. IT IS UNKNOWN IF THE DIRECT STENTING AND IMPLANTING IN A RE-STENOSED LESION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT DIRECT STENTING IN THE RESTENOSED MID RIGHT CORONARY ARTERY WITH ONE 4.0 X 28 XIENCE V STENT. ON (B)(6) 2010, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH PROGRESSIVE CHEST PAIN. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE TARGET LESION. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    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-CLONMEL 7111441

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R