BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1676599 · Received May 5, 2010

    Report

    Report Number
    2024168-2010-00914
    Event Type
    Death
    Date Received
    May 5, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 13, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. DEATH AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). 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. THE SECOND XIENCE V 3.0 X 28 (PART 1009529-28, LOT 9091541), INDICATED IS BEING FILED UNDER THIS MFR #.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: ACUTE STENT THROMBOSIS/DEATH. ONSET OF ADVERSE EVENT: DURING THE PROCEDURE POST STENT DEPLOYMENT. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ACUTE MYOCARDIAL INFARCTION AND PRIMARY ANGIOPLASTY WAS DONE. THERE WERE TWO LESIONS, ONE AT THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) AND THE OTHER AT THE DISTAL LAD. FIRST A WHISPER ES GUIDE WIRE WAS ADVANCED PAST THE LESIONS. THEN PRE DILATATION WAS DONE WITH A VOYAGER 2.0 X 15 BALLOON CATHETER. A XIENCE V 3.0 X 28 WAS DEPLOYED IN THE DISTAL LAD AND A XIENCE V 3.0 X 23 MM STENT WAS DEPLOYED IN THE PROXIMAL LAD. JUST AFTER THE DEPLOYMENT OF THE STENTS, THE PT DIED ON THE TABLE. LATER, THE DOCTOR REPORTED THAT THIS WAS A CAUSE OF STENT THROMBOSIS. NO ADDITIONAL EVENT OR PT 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 CLONMEL NA 9112541

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death LOT 9091541)| DILATATION CATHETER: VOYAGER| STENT: XIENCE V 3.0X28 (PART 1009529-28,| GUIDE WIRE: WHISPER