BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1253781 · Received December 5, 2008

    Report

    Report Number
    2024168-2008-01305
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 6, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING DETERMINED THAT MYOCARDIAL INFARCTION, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY ISSUE. THERE WAS NO REPORT OF ANY DEVICE MALFUNCTION AT THE TIME OF THE STENT IMPLANT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT IS LIKELY THAT THE ELEVATED ENZYMES ARE A SECONDARY EFFECT OF THE MYOCARDIAL INFARCTION. A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT EFFECTS, AND THE RELATIONSHIP TO THE DEVICES, IF ANY, CANNOT BE DETERMINED. THE XIENCE V RX 3.0X28MM MENTIONED IN B5 AND D11 IS BEING FILED UNDER THE SAME MFR NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY- PERMANENT DAMAGE. REPORTING RATIONALE: MYOCARDIAL INFARCTION; PERMANENT DAMAGE. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT IN 2008, A XIENCE 2.75X23 WAS IMPLANTED IN THE DISTAL RCA AND A XIENCE 3.0X28 WAS IMPLANTED IN THE DISTAL LAD. POST PROCEDURE AND BEFORE DISCHARGE, A MYOCARDIAL INFARCTION (MI) OCCURRED. THERE WAS PERIPROCEDURAL SIGNIFICANT INCREASE OF CK-MB AND TNT WITH SLIGHT INCREASE OF TOTAL CK. NO ACTION WAS TAKEN AND THE ADVERSE EVENT WAS RESOLVED ABOUT TWO DAYS LATER. THE PT WAS DISCHARGED TWO DAYS POST PROCEDURE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability LOT# UNK| STENT: XIENCE V RX 3.0X28MM