BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1971817 · Received January 27, 2011

    Report

    Report Number
    2024168-2011-00487
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    September 1, 2010
    Report Date
    January 6, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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. ANGINA AND STENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE INSTRUCTIONS FOR USE. 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY TWENTY TWO MONTHS POST XIENCE V STENT IMPLANTATION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD) THE PATIENT EXPERIENCED CHEST PAIN WITH DIAPHORESIS AND SHORTNESS OF BREATH. ON (B)(6) 2010, THE LEFT HEART CATHETERIZATION REVEALED MINIMAL IN-STENT STENOISIS IN THE INDEX TARGET LESION WITH NO MORE THAN 20% RESIDUAL STENOSIS. TREATMENT INCLUDED MEDICAL MANAGMENT ONLY. 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 8051462

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| S VESSEL CLOSURE: ANGIO-SEAL