BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1406684 · Received June 22, 2009

    Report

    Report Number
    2024168-2009-01106
    Event Type
    Injury
    Date Received
    June 22, 2009
    Date of Event
    May 4, 2009
    Report Date
    May 28, 2009
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XIENCE V 3.0 X 12 MM(LOT# 8071561) IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER. ANGINA AND RESTENOSIS AS LISTED IN THE IFU, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH STENTING. ADDITIONALLY, ANGINA, RESTENOSIS, AND HOSPITALIZATION ARE LISTED IN THE RISK ASSESSMENT AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A SDS QUALITY DEFICIENCY. IT IS POSSIBLE THAT THE ANGINA IS A SECONDARY EFFECT OF THE RESTENOSIS, WHICH WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY AND HOSPITALIZATION. A CONCLUSIVE ROOT CAUSE 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 MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT IN 2008, THE PATIENT UNDERWENT STENTING OF THE PRE-DILATED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE PRE-DILATED RESTENOSED PROXIMAL CIRCUMFLEX WITH TWO XIENCE V STENTS. IN 2009, THE PATIENT EXPERIENCED EXERTIONAL ANGINA. THREE DAYS LATER, ANGIOGRAM RESULTS REVEALED 95% IN-STENT RESTENOSIS WITHIN THE PROXIMAL LAD AND PROXIMAL CIRCUMFLEX. THE PROXIMAL LAD WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY ONLY, AND THE PROXIMAL CIRCUMFLEX WAS TREATED WITH CUTTING BALLOON ANGIOPLASTY AND PLACEMENT OF ANOTHER COMPANY'S DRUG ELUTING STENT. THE PATIENT WAS DISCHARGED HOME THE FOLLOWING DAY. THERE IS NO ADDITIONAL PATIENT OR EVENT INFORMATION 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 8051262

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R (LOT# 8071561)| XIENCE V 3.0 X 12 MM