BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1783752 · Received July 28, 2010

    Report

    Report Number
    2024168-2010-01508
    Event Type
    Death
    Date Received
    July 28, 2010
    Date of Event
    February 21, 2010
    Report Date
    July 6, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE XIENCE V 2.5 X 28 (PART 1009539, LOT 9112461) AND XIENCE V 3.0 X 28 (PART 1009541-28, LOT 911941) INDICATED ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. THE STENT REMAINS IN THE PT. THE LOT NUMBER WAS PROVIDED. A F/U REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFO.

    Description of Event or Problem · 1

    DEVICE ISSUE: RESISTANCE. ADVERSE EVENT: THROMBOSIS/INTERVENTION/DEATH. ONSET OF ADVERSE EVENT: 4-DAYS POST-PROCEDURE. IT WAS REPORTED THAT A PROCEDURE WAS PERFORMED ON (B) (6)2010 TO TREAT THE HEAVILY CALCIFIED AND 100% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). AFTER PRE-DILATATION, A XIENCE V 2.5 X 28 STENT SYSTEM WAS ADVANCED; HOWEVER, THE STENT SYSTEM WAS NOT ABLE TO CROSS THE LESION. TWO NON-ABBOTT GUIDING CATHETERS, 5F AND 7F, WERE INSERTED AND THE 2.5 X 28 XIENCE V WAS RE-ADVANCED, AS WELL AS A XIENCE V 2.5 X 28 AND A XIENCE V 3.0 X 28. ALL STENTS WERE DEPLOYED SUCCESSFULLY FROM THE DISTAL LESION TO THE PROXIMAL LESION. POST DILATATION WAS PERFORMED AND INTRAVASCULAR ULTRA SOUND CONFIRMED THAT ALL THREE XIENCE STENTS WERE EXPANDED WELL AND THE PROCEDURE WAS COMPLETED. ON (B) (6)2010, THE PT'S RESPIRATORY STATUS WORSENED DUE TO HEART FAILURE AND PNEUMONIA; STEROIDS WERE ADMINISTERED. ON (B) (6)2010, BRADYCARDIA AND CARDIO PULMONARY ARREST WERE DIAGNOSED. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED AND THROMBOSIS WAS FOUND IN THE LEFT MAIN AND IN ALL THREE XIENCE V STENTS. ASPIRATION WAS PERFORMED AND BLOOD FLOW WAS RESTORED TO TIMI GRADE 3. THE PT WAS COMATOSE AND PLACED ON PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS). ON (B) (6)2010, THE PCPS TUBE WAS REMOVED AND THE PT DIED. REPORTEDLY, THE LAD MAY HAVE BEEN INJURED BY THE 5F AND 7F GUIDING CATHETER TECHNIQUE CAUSING THROMBOSIS. THOUGH REQUESTED, NO ADD'L INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 9121141

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death XIENCE V 3.0 X 28| IRONMAN| FORTIS 2.5 X 13| (PART 1009541-28, LOT 911941)| (PART 1009539, LOT 9112461)| VAC: XIENCE V 2.5 X 28| HEARTRAIL 5F ST| GUIDE CATH: LAUNCHER 7F EU3.75| GUIDE WIRE: RINATO| DIL CATH: SPRINTER LEGEND 2.0 X 15