BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1242215 · Received November 19, 2008

    Report

    Report Number
    2024168-2008-01172
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XIENCE V (PART# 1009551-18/LOT# 70227P5) IS BEING FILED UNDER THE SAME MFR NUMBER. RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. ANGINA, AS LISTED IN THE INSTRUCTIONS FOR USE AND PRODUCT RISK ASSESSMENT (RAM), IS A KNOWN RISK ASSOCIATED WITH CORONARY STENTING. DIAPHORESIS (SWEATING) AND HOSPITALIZATION ARE LISTED IN THE RAM AS NO-FAULT POST-PROCEDURE COMPLICATIONS. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A STENT DELIVERY SYSTEM QUALITY PROBLEM. A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT ISSUES, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: PT REQUIRED MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT APPROX 14 MOS AFTER THE TWO 2.5X18MM XIENCE V STENTS WERE IMPLANTED, THE PT EXPERIENCED ANGINA, NAUSEA AND DIAPHORESIS (SWEATING). A DIAGNOSTIC CORONARY ANGIOGRAPHY WAS DONE AND REVASCULARIZATION WAS PERFORMED AND A PROMUS STENT WAS PLACED IN THE DISTAL LAD. NO ADD'L 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 70227P5

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R XIENCE V 2.5X18MM (PART# 1009551-18/LOT# 70227P5)