BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2093771 · Received May 18, 2011

    Report

    Report Number
    2024168-2011-03535
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    May 18, 2010
    Report Date
    April 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, STENOSIS, MI AND ISCHEMIA ARE LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IT WAS REPORTED THAT THE XIENCE STENT WAS IMPLANTED WITH OUT PRE-DILATATION (DIRECT STENTING). IT SHOULD BE NOTED THAT THE IFU STATES TO PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. IT IS NOT LIKELY THAT THE LACK OF PRE-DILATATION CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS THAT OCCURRED NINE MONTHS AFTER THE INDEX PROCEDURE. 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, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2009 THE PATIENT UNDERWENT DIRECT STENTING IN THE FIRST DIAGONAL ARTERY WITH TWO 2.5 X 8 XIENCE V STENTS. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN AND WAS FOUND TO HAVE ELEVATED TROPONIN LEVELS AND A POSITIVE FUNCTIONAL ISCHEMIA STUDY. THE PATIENT UNDERWENT A DOUBLE CORONARY ARTERY BYPASS GRAFT IN THE TARGET VESSEL, BUT NON-TARGET LESION. THE PATIENT CONDITION RESOLVED ON (B)(6) 2010. THE ABBOTT VASCULAR CLINICAL EVENTS COMMITTEE ADJUDICATED THIS EVENT AS A NON Q MYOCARDIAL INFARCTION (MI) AND ADJUDICATED THE REVASCULARIZATION AS OCCURRING IN THE DIAGONAL INDEX LESION AND IN THE MID LEFT ANTERIOR DESCENDING ARTERY (TARGET VESSEL/NON-TARGET LESION). 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-TEMECULA-CT 806026I

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R| S STENT: 2.5 X 8 XIENCE V