BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1564412 · Received December 22, 2009

    Report

    Report Number
    2024168-2009-02430
    Event Type
    Death
    Date Received
    December 22, 2009
    Date of Event
    October 5, 2009
    Report Date
    December 2, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE THREE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INDICATED ARE BEING FILED UNDER THE SAME MFR NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: DEATH. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA TRIAL THAT THE INDEX PROCEDURE WAS IN 2008. NO PREDILATATION WAS PERFORMED ON ANY OF THE TARGET LESIONS PRIOR TO STENTING. ONE XIENCE V STENT 1009547-28 / 8040161 WAS IMPLANTED IN THE DISTAL CX. TWO XIENCE V STENT 1009545-28 / 8040361 AND 1009546-23 / 8051461 WERE IMPLANTED IN THE DISTAL RCA OVERLAPPING. ONE XIENCE V STENT 1009547-12 / 8010761 WAS IMPLANTED IN THE PROX RCA. BEGINNING IN 2009, THE PT WAS EXPERIENCING CHEST PAIN; HOWEVER, NO TREATMENT WAS PERFORMED AT THIS TIME. THE FOLLOWING MONTH, THE PT WAS STILL EXPERIENCING CHEST PAIN AND WAS REHOSPITALIZED FOR A PROCEDURE TO REDO A SEVERELY STENOSED CORONARY ARTERY BYPASS GRAFT PREVIOUSLY PERFORMED ON THE PT. (THIS IS ASSUMING THE PROCEDURE WAS PERFORMED PRIOR TO THE PT EXPIRING.) IT WAS ALSO REPORTED THAT THE PT EXPIRED. NO ADDITIONAL EVENT OR PT INFORMATION HAS BEEN REPORTED.

    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 8040161

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| H| R (PART# 1009545-28, LOT# 8040361| PART# 1009547-12, LOT# 8010761)| STENT SYSTEMS| PART# 1009546-23, LOT# 8051461| STENTS: XIENCE V EVEROLIMUS ELUTING CORONARY