BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2025270 · Received March 21, 2011

    Report

    Report Number
    2024168-2011-01869
    Event Type
    Injury
    Date Received
    March 21, 2011
    Date of Event
    July 26, 2009
    Report Date
    January 18, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. PLACED IN RESTENOSED STENTS. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND MYOCARDIAL INFARCTION (MI) ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU), AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. 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 AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. IT WAS REPORTED THAT THE XIENCE STENT WAS IMPLANTED IN A RE-STENOSED DRUG ELUTING STENT. IT SHOULD BE NOTED THAT THE IFU STATES THAT 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 (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. IN THIS CASE, IT IS UNKNOWN IF THIS CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 8 MONTHS POST XIENCE V STENT IMPLANTATION INTO A RESTENOSED DRUG ELUTING STENT IN THE FIRST OBTUSE MARGINAL ARTERY (1OM) AND A DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) THE PATIENT EXPERIENCED CHEST PAIN WHICH WAS DIAGNOSED AS A SMALL MYOCARDIAL INFARCTION. MEDICAL TREATMENT WAS PROVIDED. STATUS OF THE STENTED AREAS IS UNKNOWN. ON (B)(6) 2009, THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION RECEIVED, STATES THAT IT CANNOT BE DETERMINED IF THE MYOCARDIAL INFARCTION WAS CAUSED BY THE TARGET LESIONS STENTED WITH XIENCE V STENTS.

    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 8071461

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R| S XIENCE V 3.0X15MM X2, CLOPIDOGREL, ASPIRIN.