BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1201794 · Received October 15, 2008

    Report

    Report Number
    2024168-2008-00948
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 15, 2008
    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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. STENOSIS, AS LISTED IN THE XIENCE V IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. THIS EFFECT IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THE HOSPITALIZATION WAS THE RESULT OF THE RESTENOSIS, ALTHOUGH THE TYPE OF TREATMENT WAS NOT REPORTED. ADDITIONALLY, THERE WAS NO REPORTED DEVICE MALFUNCTION AT THE TIME OF THE PROCEDURE. A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE XIENCE V STENT DELIVERY SYSTEM.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NONE. IT WAS REPORTED VIA TRIAL THAT THE VESSELS TREATED DURING THE INDEX PROCEDURE WERE THE MID LAD AND PROXIMAL RCA. REVASCULARIZATION WAS PERFORMED ON THE MID LAD DUE TO RESTENOSIS DURING WHICH A XIENCE V STENT WAS PLACED FOR TREATMENT. NO ADDITIONAL EVENT OR PATIENT INFORMATION 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 60617P3

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R