BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1582032 · Received January 15, 2010

    Report

    Report Number
    2024168-2010-00087
    Event Type
    Death
    Date Received
    January 15, 2010
    Date of Event
    December 21, 2009
    Report Date
    December 23, 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
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SECOND XIENCE V 3.5 X 28 MM (PART# 1009530-28/LOT# 9060341) MENTIONED IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: DEATH. REPORTING RATIONALE: THE PATIENT DIED. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PATIENT HAD BEEN DIAGNOSED WITH TRIPLE VESSEL DISEASE. THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS THE FIRST VESSEL TO BE TREATED; HOWEVER, IT WAS TOTALLY OCCLUDED AND AFTER ALMOST AND HOUR OF PROCEDURE TIME FINALLY FAILED. THE LEFT CIRCUMFLEX (LCX) WAS THE SECOND TREATED VESSEL AND HAD ALMOST 50% STENOSIS IN THE MIDDLE OF THE SITE. TWO XIENCE V STENTS, A 2.75 X 28 MM AND A XIENCE V 3.5 X 28 MM WERE IMPLANTED IN THE TARGET VESSEL. THE RIGHT CORONARY ARTERY (RCA) WAS THE THIRD TREATED VESSEL. THERE WAS ALMOST 80% STENOSIS IN THE PROXIMAL RCA. ANOTHER COMPANY'S DRUG ELUTING STENT WAS IMPLANTED. WITHIN FIVE (5) HOURS IN THE SAME DAY, THE PATIENT'S CONDITION WORSENED AND THE PATIENT HAD LOW BLOOD PRESSURE. ANGIOGRAPHY REVEALED THAT THERE WAS NO BLOOD FLOW IN THE TREATED LEFT CIRCUMFLEX. THE RIGHT CORONARY ARTERY STILL HAD BLOOD FLOW. SINCE THE PATIENT'S CONDITION WAS BAD, CPR WAS STARTED AND THE PATIENT UNDERWENT A CORONARY ARTERY BYPASS GRAFT (CABG). AFTER CABG, THE PATIENT'S CONDITION DID NOT IMPROVE AND THE PATIENT EXPIRED IN 2009. THE PHYSICIAN ASSUMES THAT THERE MUST HAVE BEEN ACUTE THROMBOSIS IN THE LEFT CIRCUMFLEX VESSEL CAUSED BY THE DRUG ELUTING STENTS THAT WERE IMPLANTED. NO ADDITIONAL EVENT OR PATIENT 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-CARDIAC THERAPIES NA 9061841

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death| H| L| R GUIDE WIRE: RUNTHROUGH NS| (PART# 1009530-28/LOT# 9060341)| GUIDE CATHETER: CORDIS JL| TERUMO| XIENCE V 3.5 X 28 MM