BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1425434 · Received July 30, 2009

    Report

    Report Number
    2024168-2009-01364
    Event Type
    Death
    Date Received
    July 30, 2009
    Date of Event
    June 1, 2009
    Report Date
    July 6, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - DEATH IS LISTED IN THE IFU AS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. THERE WAS NO REPORT OF ANY PRODUCT MALFUNCTION THAT COLD HAVE CONTRIBUTED TO THE DEATH. ALTHOUGH, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY, A CAUSE FOR THE REPORTED PT EFFECT, AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. DIRECT STENTING WAS PERFORMED WITH THE 4.0X18MM XIENCE V STENT. THE IFU STATES THAT 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. THE OTHER THREE XIENCE V STENT INDICATED IN B5 AND D11 ARE BEING REPORTED UNDER THIS MDR #.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT THE INDEX PROCEDURE WAS TO TREAT TWO VESSELS IN 2008. THE FIRST LESION TREATED WAS IN THE DISTAL RIGHT CORONARY ARTERY (RCA), WHICH WAS PRE-DILATED AND A 3.5 X 15MM XIENCE V STENT WAS IMPLANTED. THEN PRE-DILATATION WAS PERFORMED IN THE MID RCA LESION AND A 3.5 X 18 MM XIENCE V STENT WAS DEPLOYED. THE PROXIMAL RCA WAS ALSO DIRECTLY STENTED WITH A 4.0 X 18 MM XIENCE V STENT. AT APPROXIMATELY 36 DAYS LATER, THE PT HAD A SECOND PROCEDURE TO TREAT THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION AND AFTER PRE-DILATING THE LESION, A 3.5X18MM XIENCE V WAS IMPLANTED. NO PROCEDURAL COMPLICATIONS WERE NOTED DURING EITHER PROCEDURE. HOWEVER, ON 07/06/2009, NOTIFICATION WAS RECEIVED VIA THE PT'S SPONSOR THAT THE ANGINA QUESTIONNAIRE (SAQ) WAS RETURNED BECAUSE THE PT DIED. NO OTHER EVENT OR PT INFO 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 8052041

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death XIENCE V 4.0 X 18MM (1009543-18/8061261)| STENT: XIENCE V 3.5 X 28MM (1009542-28/8022261)| XIENCE V 3.5 X 18MM (1009542-28/8073062)