BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4090609 · Received September 15, 2014

    Report

    Report Number
    2024168-2014-05930
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    July 4, 2012
    Report Date
    August 21, 2014
    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). DEVICE IMPLANTED IN A RESTENOSED LESION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE WAS NO REPORTED DEVICE MALFUNCTION. THE REPORTED PATIENT EFFECT OF RESTENOSIS, AS LISTED IN THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. IT SHOULD BE NOTED THE IFU STATES: 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. SAFETY AND EFFECTIVENESS OF THE XIENCE STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. 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 THAT ON (B)(6) 2010, 4 XIENCE V STENTS WERE SUCCESSFULLY IMPLANTED IN THE RESTENOSED PROXIMAL LEFT ANTERIOR DESCENDING (PLAD), DE NOVO 1ST OBTUSE MARGINAL (OM), DE NOVO RIGHT POSTERIOR DESCENDING (RPDA) AND DE NOVO DISTAL RIGHT CORONARY ARTERIES (DRCA). ON (B)(6) 2012, APPROXIMATELY 2 YEARS POST STENT IMPLANTATION, RESTENOSIS WAS NOTED. ON (B)(6) 2013, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2013, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED IN THE TARGET LESION, RESOLVING THE EVENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569674 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0020141

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R STENT: XIENCE V 2.5X18MM, 2.5X28MM X2