BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2060321 · Received April 15, 2011

    Report

    Report Number
    2024168-2011-02685
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. MYOCARDIAL INFARCTION AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS 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. SINCE IT WAS REPORTED THAT THE PATIENT WAS NOT COMPLIANT WITH POST-PROCEDURE INSTRUCTIONS AND DID NOT FILL HER PRESCRIPTION FOR PLAVIX, IT SHOULD BE NOTED THAT THE XIENCE V IFU CAUTIONS THAT: IT IS VERY IMPORTANT THAT THE PATIENT IS COMPLIANT WITH THE POST-PROCEDURAL ANTIPLATELET THERAPY RECOMMENDATIONS. EARLY DISCONTINUATION OF PRESCRIBED ANTIPLATELET MEDICATION COULD RESULT IN A HIGHER RISK OF THROMBOSIS, MI, OR DEATH. IT IS POSSIBLE THAT THE PATIENT NOT TAKING HER PLAVIX CONTRIBUTED TO THE REPORTED THROMBOSIS AND MYOCARDIAL INFARCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A 2.5 X 23 MM OTW XIENCE V STENT IMPLANTED ON 03/03/2011 AND WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY. THE PATIENT WAS NOT COMPLIANT WITH POST PROCEDURE INSTRUCTIONS, AS SHE DID NOT FILL THE PRESCRIPTION FOR PLAVIX AND CONTINUED SMOKING. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2011 WITH ACUTE MYOCARDIAL INFARCTION. SUB-ACUTE STENT THROMBOSIS WAS NOTED. AN ASPIRATION CATHETER WAS USED AND MULTIPLE BALLOON INFLATIONS WERE PERFORMED FOR TREATMENT OF THE THROMBOSIS. THE PATIENT DID FINE AND IS AT AN ACUTE CARE FACILITY. NO ADDITIONAL INFORMATION WAS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R| S