BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1971105 · Received January 26, 2011

    Report

    Report Number
    2024168-2011-00470
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    April 23, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE 3.0 X 28 MM XIENCE V ((B)(4)) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, RE-STENOSIS AND ISCHEMIA ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THREE YEARS POST STENTING PROCEDURE IN THE PROXIMAL AND DISTAL LEFT ANTERIOR DESCENDING ARTERY WITH TWO XIENCE V STENTS, ONE 2.5 X 18 AND ONE 3 X 28, THE PATIENT EXPERIENCED EXACERBATION OF ANGINA AND WAS FOUND TO HAVE A POSITIVE FUNCTIONAL STRESS TEST DEMONSTRATING MYOCARDIAL ISCHEMIA. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY TRANSLUMINAL ANGIOPLASTY ON (B)(6) 2010 FOR INDEX LESION STENOSIS. THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. THERE WAS NO ADVERSE PATIENT SEQUELA. THOUGH 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 60617P3

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R STENT: 3.0 X 28 MM XIENCE V ((B)(4))