BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2174095 · Received July 24, 2011

    Report

    Report Number
    2024168-2011-05109
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    November 26, 2010
    Report Date
    June 29, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, STENOSIS AND MYOCARDIAL INFARCTION (MI) ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE 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, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 2 YEARS POST XIENCE V STENT IMPLANTATION IN THE 2ND OBTUSE MARGINAL ARTERY (2OM), THE PATIENT EXPERIENCED A SUDDEN ONSET OF CHEST DISCOMFORT. THE SYMPTOMS RESOLVED WITHIN 15 MINUTES, BUT THE EVENT WAS DIAGNOSED AS A NON-ST ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ON (B)(6) 2010, ANGIOGRAM SHOWED A WIDELY PATENT XIENCE V STENT IN THE 2OM; HOWEVER, WITHIN 5MM OF THE DISTAL STENT EDGE WAS A NEW LESION WHICH WAS STENTED IN AN OVERLAPPING FASHION WITH A DRUG ELUTING STENT. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED AND ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED. 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 7110861

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R| S