BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1903893 · Received November 20, 2010

    Report

    Report Number
    2024168-2010-02479
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 26, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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) INDICATION FOR USE. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). 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. IT WAS REPORTED THE XIENCE V STENT WAS USED TO TREAT IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED STENT. IT SHOULD BE NOTED THE IFU STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. ADDITIONALLY, THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008, THE PATIENT UNDERWENT STENTING IN THE PREDILATED, RESTENOSED, MID LEFT ANTERIOR DESCENDING ARTERY WITH ONE XIENCE V STENT. A NON-ABBOTT STENT HAD RESTENOSED IN THE TARGET LESION. ON (B)(6) 2010, THE PATIENT EXPERIENCED CHEST PAIN AND WAS EVALUATED IN THE EMERGENCY ROOM ON (B)(6) 2010, AND ADMITTED TO THE HOSPITAL. THE PATIENT UNDERWENT A DIAGNOSTIC CORONARY ANGIOGRAM AND WAS FOUND TO HAVE IN-STENT RESTENOSIS REQUIRING PERCUTANEOUS CORONARY INTERVENTION WITH ADDITIONAL STENTING. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010, AND WAS DISCHARGED 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-TEMECULA 8071561

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R