BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1200665 · Received October 17, 2008

    Report

    Report Number
    2024168-2008-00979
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    May 6, 2008
    Report Date
    September 24, 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
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION: PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. RESTENOSIS, AS LISTED IN THE XIENCE INSTRUCTIONS FOR USE (IFU), IS A KNOWN RISK ASSOCIATED WITH CORONARY STENTING AN IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF STENT IMPLANT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IN THIS CASE, IT IS LIKELY THAT THE HOSPITALIZATION IS A SECONDARY EFFECT OF THE RESTENOSIS. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR INJURY. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE INDEX PROCEDURE WAS PERFORMED IN 2007. THE 3.5 X 23 CM XIENCE V STENT WAS DEPLOYED IN THE PROXIMAL CIRCUMFLEX. THE PROCEDURE WAS SUCCESSFUL AND THERE WERE NO REPORTED PATIENT EFFECTS OR PRODUCT ISSUES. IN 2008, THE PATIENT PRESENTED WITH RESTENOSIS IN THE PROXIMAL CIRCUMFLEX, WHICH REQUIRED TREATMENT WITH A DRUG ELUTING STENT. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R