BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1242214 · Received November 19, 2008

    Report

    Report Number
    2024168-2008-01184
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    October 23, 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
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT. ANGINA AND STENOSIS, AS LISTED IN THE XIENCE V IFU, ARE KNOWN RISK ASSOCIATED WITH CORONARY STENTING AND ARE 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 ANGINA AND DYSPNEA ARE SECONDARY EFFECTS OF THE STENOSIS WHICH RESULTED IN REVASCULARIZATION AND HOSPITALIZATION. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED PT 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. DEVICE ISSUE: NO DEVICE ISSUE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT THE INDEX PROCEDURE TOOK PLACE IN 2007 DURING WHICH A XIENCE V STENT WAS DEPLOYED IN THE MID RCA. IN 2008, THE PT WAS EXPERIENCING SYMPTOMS OF ANGINA AND SHORTNESS OF BREATH. A CORONARY ANGIOGRAPHY WAS PERFORMED. IN 2008 THE PT UNDERWENT REVASCULARIZATION, AND A XIENCE V WAS IMPLANTED SUCCESSFULLY IN THE MID RCA. PREDILATION WAS PERFORMED PRIOR TO STENT DEPLOYMENT. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R