BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1369857 · Received April 27, 2009

    Report

    Report Number
    2024168-2009-00721
    Event Type
    Injury
    Date Received
    April 27, 2009
    Date of Event
    March 10, 2009
    Report Date
    April 3, 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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XIENCE V 2.5 X 28 MM (LOT#8071761) IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER. ANGINA AND ISCHEMIA ARE RISKS OF STENTING, AND ARE LISTED IN THE IFU. THESE PATIENT EFFECTS ALONG WITH HOSPITALIZATION ARE LISTED IN THE RISK ASSESSMENT AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT DEFICIENCY. THE IFU STATES: THE VESSEL SHOULD BE PRE-DILATED WITH AN APPROPRIATE SIZED BALLOON. FAILURE TO DO SO MAY INCREASE THE DIFFICULTY OF STENT PLACEMENT AND CAUSE PROCEDURAL COMPLICATIONS. IT IS NOT KNOWN HOW DIRECT STENTING THE LESION MAY BE RELATED TO THE PATIENT EFFECTS, IF AT ALL.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY-MEDICAL INTERVENTION. REPORTING RATIONALE: ANGINA AND ISCHEMIA REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT APPROXIMATELY TWENTY ONE (21) DAYS AFTER A 2.5 X 15 MM XIENCE V STENT AND A 2.5 X 28 MM XIENCE V STENT WERE IMPLANTED, THE PATIENT COMPLAINED OF CHEST DISCOMFORT, AND AN ABNORMAL STRESS TEST WAS CONSISTENT WITH SEVERE ISCHEMIA INVOLVING THE LEFT ANTERIOR DESCENDING ARTERY (LAD). PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED AS TREATMENT. ADDITIONALLY, NO PRE-DILATATION WAS PERFORMED PRIOR TO IMPLANTING THE 2.5 X 15 MM XIENCE V STENT (CONTRARY TO IFU). 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 8071561

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R XICNE V 2.5 X 28 MM (LOT#8071761)