BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1748940 · Received July 2, 2010

    Report

    Report Number
    2024168-2010-01330
    Event Type
    Injury
    Date Received
    July 2, 2010
    Date of Event
    May 21, 2010
    Report Date
    June 9, 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
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4): THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP WILL BE SUBMITTED WITH ANY RELEVANT INFORMATION. THE RX XIENCE V 2.5 X 28(PART #1009539-28/LOT #8082761) AND RX XIENCE V 3.0 X 28 (PART #1009541-28/LOT #808156) MENTIONED WERE FILED UNDER MFR REPORT# 2024168-2010-01308.

    Description of Event or Problem · 1

    ADVERSE EVENT: STENOSIS REQUIRING INTERVENTION. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED VIA A TRIAL THAT ON (B) (6)2009, THE PATIENT UNDERWENT STENTING IN THE PREDILATED, MODERATELY CALCIFIED RIGHT POSTERIOR DESCENDING ARTERY LESION WITH THREE XIENCE V STENTS. ON (B) (6)2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR INCREASING SHORTNESS OF BREATH AND OTHER UNSPECIFIED SYMPTOMS THAT WERE SIMILAR TO THOSE EXPERIENCED PRIOR TO THE INDEX PROCEDURE. A NUCLEAR STRESS TEST SHOWED POSSIBLE ISCHEMIA IN THE INFERIOR WALL RESULTING IN A DIAGNOSTIC CORONARY ANGIOGRAPHY AND PERCUTANEOUS CORONARY INTERVENTION IN THE TARGET LESION. AN ECG AND CARDIAC ENZYMES SHOWED NO MYOCARDIAL INFARCTION. THE PATIENT'S CONDITION RESOLVED ON (B) (6)2010 AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION 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 9051261

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R RX XIENCE V 2.5 X 28(PART#1009539-28/LOT#8082761)| LOT #8081561),| VESSEL CLOSURE: MINX CLOSURE SYSTEM| AND RX XIENCE V 3.0 X 28 (PART#1009541-28/