BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2094052 · Received May 18, 2011

    Report

    Report Number
    2024168-2011-03539
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 24, 2011
    Report Date
    April 26, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. CONCOMITANT MEDICAL PRODUCTS: STENT: 2.5 X 18 AND 2.75 X 15 MM XIENCE V; OTHER: ASPIRIN, CLOPIDOGREL. THE RX XIENCE V 2.75 X 15 MM IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. (B)(4): NO PRE-DILATATION THE STENT REMAINS IN THE PATIENT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, MYOCARDIAL INFARCTION, 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, 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 PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER FOR THE VESSEL/LESION TO BE TREATED. THE DIRECT STENTING DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS THAT OCCURRED THIRTY MONTHS AFTER THE INDEX PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT ON (B)(6) 2008 THE PATIENT UNDERWENT DIRECT STENTING IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH TWO XIENCE V STENTS (2.5 X 23 AND 2.5 X 18) AND IN THE RESTENOSED, FIRST OBTUSE MARGINAL ARTERY WITH ONE XIENCE V STENT (2.75 X 15). ON (B)(6) 2011, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN AND WAS FOUND TO HAVE AN ACUTE MYOCARDIAL INFARCTION (MI). THE PATIENT UNDERWENT AN ANGIOGRAM AND SUBSEQUENT PERCUTANEOUS CORONARY INTERVENTION (PCI) IN THE LAD WITH A LONG, MID TO DISTAL SEGMENT WITH DISCRETE 90% IN-STENT RESTENOSIS JUST AFTER A DIAGONAL BRANCH. THE NON-TARGET DISTAL LEFT CIRCUMFLEX ARTERY ALSO HAD 90% IN-STENT RESTENOSIS AND THE FIRST OBTUSE MARGINAL ARTERY WAS ALSO TREATED VIA PCI. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 AND RE-ADMITTED ON (B)(6) 2011 WITH CHEST PAIN. THERE WAS NO FURTHER INTERVENTION PERFORMED. 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 8051461

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R| S