BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3757879 · Received April 17, 2014

    Report

    Report Number
    2024168-2014-02421
    Event Type
    Death
    Date Received
    April 17, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 25, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CINE FILE, SENT WITH THE CASE, WAS REVIEWED BY AN ABBOTT VASCULAR PHYSICIAN/CLINICAL SPECIALIST. THE REVIEWER CONCLUDED AN EXTREMELY COMPLEX HYBRID PROCEDURE WITH WHAT APPEARS TO HAVE BEEN AN UNRESOLVED DISSECTION BETWEEN THE IMPLANT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE METALLIC STENT IN THE PROXIMAL LAD/LEFT MAIN. FROM THE FILMS IT IS IMPOSSIBLE TO DISCERN WHETHER THE STENT THROMBOSIS WAS SECONDARY TO THE METALLIC STENT, THE DISSECTION, OR THE IMPLANT. THE REPORTED PATIENT EFFECTS OF CORONARY OR STENT THROMBOSIS AND DEATH ARE LISTED IN THE EVEROLIMUS ELUTING CORONARY STENT SYSTEM, INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT 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.

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE ON (B)(6)-2014 WAS TO TREAT A MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AT THE OSTIUM AND 99% AT THE PROXIMAL SECTION. A 3.5 X 18 IMPLANT WAS DEPLOYED AND POST-DILATED WITH A GOOD RESULT ANGIOGRAPHICALLY. DURING THE PROCEDURE A STRONG STENOSIS WAS NOTED A THE BIFURCATION FROM THE OSTIUM OF THE LAD TO THE CIRCUMFLEX (CX). DURING PRE-DILATATION OF THIS AREA WITH A 4.0 AND 4.5 BALLOON, A DISSECTION OCCURRED. THE DISSECTION WAS TREATED WITH A 2.5 X 18 MM IMPLANT AS WELL AS A 3.0 X 18 XIENCE STENT (SPECIFIC TYPE OF XIENCE IS UNKNOWN). THE RESULT LOOKED GOOD, BUT 50% RESIDUAL STENOSIS REMAINED. ON (B)(6)-2014, THE PATIENT RETURNED FOR A PROCEDURE TO TREAT A 99% STENOSIS IN THE RIGHT CORONARY ARTERY (RCA), WHICH WAS TREATED WITH A 3.0 X 12 IMPLANT. ON (B)(6)-2014, THE PATIENT RETURNED AS EMERGENCY CASE WITH COMPLETE THROMBOTIC CLOSURE OF THE IMPLANTS IN THE LAD & RCA. THE CX WAS ONLY 70 % CLOSED BY THROMBOTIC MATERIAL. CARDIAC ARREST WAS DIAGNOSED AND RECANALIZATION PERFORMED UNDER REANIMATION. IT WAS POSSIBLE TO REOPEN THE RCA BY UNKNOWN MEANS, BUT THE LAD WAS STILL CLOSED AND COULD NOT BE REOPENED. A LUNG BLEEDING OCCURRED AND IT WAS NOT POSSIBLE TO ACHIEVE SPONTANEOUS CARDIAC ACTIVITY. PATIENT EXPIRED DUE TO CARDIAC ARREST. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234249 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3071041

    Patients

    Seq Age Sex Outcome Treatment
    1 Death OTHER: CLOPIDOREL AND ASPIRIN