BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1964262 · Received January 19, 2011

    Report

    Report Number
    2024168-2011-00377
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    August 1, 2010
    Report Date
    December 25, 2010
    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. NO PRE-DILATATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V 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, DESIGN, OR LABELING. SINCE IT WAS REPORTED THAT THE XIENCE V STENT WAS IMPLANTED VIA DIRECT STENTING, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL/LESION TO BE TREATED. IN THIS CASE, IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY TWENTY ONE MONTHS AFTER DIRECT STENTING IN THE PROXIMAL SECOND DIAGONAL BRANCH IN THE LEFT CORONARY ARTERY WITH ONE 2.5X23 XIENCE V STENT, THE PATIENT EXPERIENCED EXERTIONAL, HEAVY CHEST PRESSURE THAT WAS RELIEVED BY REST. ON (B)(6) 2010 THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION FOR 90% NEW STENOSIS IN THE MID LEFT ANTERIOR DESCENDING ARTERY AND MILD IN-STENT RESTENOSIS OF THE INDEX TARGET LESION IN THE LARGE DIAGONAL BRANCH IN THE LEFT ANTERIOR DESCENDING ARTERY. 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 8051462

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R