BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4772290 · Received May 14, 2015

    Report

    Report Number
    2024168-2015-02719
    Event Type
    Death
    Date Received
    May 14, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 29, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT AND UNDERWENT PERCUTANEOUS CORONARY INTERVENTION. THE ANGIOGRAM REVEALED THAT THROMBOSIS WAS NOTED IN THE LEFT MAIN, TIMI FLOW WAS ZERO IN THE LAD AND THE CX. ASSISTED BREATHING WAS PERFORMED WITH A VENTILATOR, A 4.0 NON-ABBOTT DIAGNOSTIC CATHETER WAS ADVANCED TO THE OPENING OF THE LEFT CORONARY ARTERY AND 8ML OF TIROFIBAN WAS INJECTED BUT TIMI FLOW WAS STILL ZERO. A BALANCE MIDDLEWEIGHT UNIVERSAL II WAS ADVANCED TO THE DISTAL LAD. A 2.0X15 MM UNSPECIFIED BALLOON CATHETER WAS ADVANCED TO THE DISTAL LAD AND WAS INFLATED TO 12 ATMOSPHERES. LITTLE BLOOD FLOW WAS NOTED. LASTLY, CARDIO-PULMONARY RESUSCITATION (CPR) WAS DONE WITHIN 60 MINUTES BUT THE PATIENT EXPIRED. NO RELATED RECORD WAS PROVIDED TO INDICATE THAT THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY (DAPT) AFTER THE PROCEDURE. THE OFFICIAL CAUSE OF DEATH WAS DUE TO THE THROMBUS. THERE WERE NO ADVERSE PATIENT EFFECTS DURING THE PROCEDURE WHEN IMPLANTING THE STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS: STENT: XIENCE XPEDITION 3.5X12, MEDICATIONS: ORAL ASPIRIN, INSULIN ASPART 30, TRIMETAZIDINE. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. ANGINA, THROMBOSIS AND DEATH ARE LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS 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 PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY. THE 3.50X12 XIENCE XPEDITION REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA, HYPERTENSION, TYPE II DIABETES, CHRONIC RENAL INSUFFICIENCY, AND HEART DYSFUNCTION. A CORONARY ANGIOGRAM WAS PERFORMED ON (B)(6) 2015 WHICH SHOWED THAT IT WAS A LEFT DOMINANT PATTERN. THERE WAS MEDIUM TO HEAVY STENOSIS IN THE DISTAL LEFT MAIN. THE OPENING OF THE CIRCUMFLEX (CX) HAD HEAVY STENOSIS AND THE DISTAL CX WAS ECCENTRIC WITH MODERATE STENOSIS AND NO TORTUOSITY. THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY HAD MILD CALCIFICATION, THE WALL OF THE MID LAD WAS NOT SMOOTH, THE DISTAL LAD HAD MODERATE STENOSIS AND THERE WAS NO TORTUOSITY IN THE LAD. THE PROXIMAL DIAGONAL 1 HAD MILD STENOSIS. ON (B)(6) 2015, A 3.5X12 MM XIENCE XPEDITION RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, THE SDS WAS INFLATED AND THE STENT WAS DEPLOYED IN THE OPENING OF THE CX. THE SDS WAS REMOVED AND POST-DILATATION WAS PERFORMED USING AN UNSPECIFIED 3.5X12 MM BALLOON CATHETER. A 3.5X15 MM XIENCE XPEDITION RX SDS WAS ADVANCED, THE SDS WAS INFLATED AND THE STENT WAS DEPLOYED IN THE DISTAL LEFT MAIN. THE SDS WAS REMOVED AND POST-DILATION WAS PERFORMED USING AN UNSPECIFIED 3.0X12 MM BALLOON CATHETER. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WHEN IMPLANTING THE STENTS. AFTER THE PROCEDURE THE ANGIOGRAM REVEALED GOOD THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) BLOOD FLOW IN THE LEFT MAIN, THE CX AND THE LAD. HOWEVER, A FEW HOURS LATER, THE PATIENT COMPLAINED OF CHEST PAIN AND EXPERIENCED CARDIOGENIC SHOCK (CGS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316465 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4091641

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death