BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2020794 · Received March 16, 2011

    Report

    Report Number
    2024168-2011-01773
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    July 20, 2010
    Report Date
    November 5, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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. NO PRE-DILATATION, PLACED IN A RESTENOSED STENT. 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 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. SINCE IT WAS REPORTED THE XIENCE V WAS USED TO TREAT IN-STENT RESTENOSIS AND THE LESION WAS NOT PRE-DILATED, 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. THE IFU CAUTIONS THAT: THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. ADDITIONALLY, THE IFU STATES TO PRE-DILATE THE LESION WITH A PTCA CATHETER. IT CANNOT BE DETERMINED HOW, IF AT ALL, THE DIRECT STENTING IN A RESTENOSED VESSEL CONTRIBUTED TO THE REPORTED PATIENT EFFECTS OCCURRING APPROXIMATELY TWENTY MONTHS AFTER THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 20 MONTHS POST DIRECT STENTING OF A XIENCE V STENT INTO A RESTENOSED NON-ABBOTT STENT IN THE FIRST DIAGONAL ARTERY (D1), THE PATIENT EXPERIENCED ANGINA. AN ANGIOGRAM WAS PERFORMED WHICH FOUND IN-STENT RESTENOSIS OF THE 3 STENTS IN THE D1. THERE WAS NO REPORTED CORONARY INTERVENTION. ALTHOUGH REQUESTED, 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 8060361

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O TAXUS STENT