BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1887527 · Received October 22, 2010

    Report

    Report Number
    2024168-2010-02240
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    December 24, 2008
    Report Date
    September 28, 2010
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENOSIS AND ANGINA ARE LISTED IN THE PRODUCT INSTRUCTION FOR USE, AS KNOWN POTENTIAL ADVERSE EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. IN THIS CASE, THE STENOSIS AND ANGINA WERE TREATED WITH BALLOON ANGIOPLASTY AND HOSPITALIZATION. THE XIENCE V (P.N. 1009539-12, LOT#: 8052762) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2008, THE PT UNDERWENT STENTING IN THE DE NOVO, FIRST OBTUSE MARGINAL LESION WITH ONE 2.5 X 12 XIENCE STENT AND IN THE DE NOVO LEFT MAIN (LMCA) TO LEFT CIRCUMFLEX (LCX) LESION WITH ONE 3.5 X 28 XIENCE STENT. IN (B)(6) 2008, THE PT REPORTED HAVING HAD ONGOING CHEST PAIN OFF AND ON OVER THE PAST THREE DAYS. THE PT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2008 AND HAD AN ANGIOGRAM THAT FOUND A 100% IN-STENT OCCLUSION AND THROMBUS IN THE FIRST OBTUSE MARGINAL. THERE WAS NO INTERVENTION WARRANTED IN THE FIRST OBTUSE MARGINAL ARTERY; RATHER, THE PT WAS GIVEN ADD'L MEDICAL THERAPY. THE 3.5 X 28 XIENCE STENT WAS FOUND TO BE PATENT AT THAT TIME. ON (B)(6) 2009, THE PT REPORTED HAVING SYMPTOMS OF ANGINA THAT WERE ACCELERATING OVER THE LAST WEEK AND REQUIRED BALLOON ANGIOPLASTY OF THE LCX, LMCA, AND LEFT ANTERIOR DESCENDING ARTERY FOR IN-STENT RESTENOSIS. THERE WAS IN-STENT RESTENOSIS OF THE STENT IN THE LCX AND LMCA. THE PT WAS DISCHARGED ON (B)(6) 2009. THERE WAS NO ADD'L INFO PROVIDED.

    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 8022261

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R STENT: XIENCE V (P.N. 1009539-12, LOT#: 8052762)