BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961871 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00323
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    September 21, 2010
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. (B)(4) NO PRE-DILATATION. STENT: XIENCE V (1009545-08, LOT# 8062361), (1009545-18, LOT#8052961), (1009545-08, LOT#8062361), XIENCE V 3X12 (UNK PART AND LOT). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ISCHEMIA AND RESTENOSIS 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 OR DESIGN. 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 THREE MONTHS POST XIENCE V STENT PLACEMENT, IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD), THE PATIENT WAS FOUND TO HAVE A POSITIVE FUNCTIONAL STRESS TEST DEMONSTRATING MYOCARDIAL ISCHEMIA. ON (B)(6) 2010 THE PATIENT UNDERWENT CORONARY ARTERY BYPASS GRAFT FOR 90% IN-STENT RESTENOIS IN THE INDEX TARGET LESION. THE PATIENT CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2010. 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 8060961

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| S CONCOMITANT MEDICAL DEVICES