BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1456828 · Received August 27, 2009

    Report

    Report Number
    2024168-2009-01550
    Event Type
    Injury
    Date Received
    August 27, 2009
    Date of Event
    August 3, 2009
    Report Date
    August 5, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RX XIENCE V 2.5 X 23 MM (PART #1009527-23/LOT #9031362), 2.5 X 08 MM (PART #1009527-08/LOT #9020661), AND 2.75 X 12 MM (PART #1009528-12/LOT #9031241) ARE BEING FILED UNDER THE SAME MFR #. MI AND NAUSEA AS NOTED IN THE IFU, ARE KNOWN ADVERSE EVENTS WITH STENTING AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. THESE PT EFFECTS, ALONG WITH HOSPITALIZATION ARE LISTED IN THE RISK ASSESSMENT. ALTHOUGH EXHAUSTION IS NOT LISTED IN THE IFU, IT COULD BE ASSOCIATED WITH MANY OTHER THINGS BESIDES THE XIENCE V STENT, SUCH AS THE OVERALL HEALTH AND CONDITION OF THE PT OR MEDICATION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: MYOCARDIAL INFARCTION TREATED WITH MEDICATION AND CAUSING PERMANENT DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAD BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT AFTER FOUR RX XIENCE V STENTS (2.5 X 18 MM, 2.5 X 23 MM, 2.5 X 08 MM, 2.75 X 12 MM) WERE IMPLANTED, THE PT FELT EXHAUSTED AND VOMITED SEVERAL HOURS FOLLOWING ANGIOGRAPHY. THEN, REPORTEDLY EXPERIENCED A PERIPROCEDURAL MYOCARDIAL INFARCTION (MI) AND WAS HOSPITALIZED AND TREATED WITH MEDICATION. THE TROPONIN MEASUREMENT WAS ABNORMAL AND CLINICALLY RELEVANT. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9040742

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R| S XIENCE V 2.75 X 12 MM| XIENCE V RX 2.5 X 23 MM| LOT #9031362| XIENCE V RX 2.5 X 08 MM| LOT# 9031241| LOT #9020661