BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1837248 · Received September 14, 2010

    Report

    Report Number
    2024168-2010-01903
    Event Type
    Death
    Date Received
    September 14, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 20, 2010
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 2.5 X 2.3 XIENCE V (1009527-23-0020941), 2.5X28 XIENCE V (1009527-28/(B)(4)) AND 2.75X23 XIENCE V (1009528-23/(B)(4)), INDICATED ARE EACH BEING FILED UNDER A SEPARATE MFR#. EVALUATION SUMMARY: THERE WAS NO REPORTED PRODUCT DEFICIENCY. ARRHYTHMIA (INCLUDES BRADYCARDIA), DEATH, AND HYPOTENSION ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). SINCE IT WAS REPORTED THAT THE PATIENT WAS NOT TAKING ASPIRIN OR CLOPIDOGREL, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES THAT: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS CONTRAINDICATED FOR USE IN PATIENTS IN WHOM ANTIPLATELET AND/OR ANTICOAGULANT THERAPY IS CONTRAINDICATED. ADDITIONALLY, THE IFU STATES THAT: ANTIPLATELET DRUGS SHOULD BE USED IN COMBINATION WITH XIENCE V. PHYSICIANS SHOULD USE THE INFORMATION FROM THE (B)(4) CLINICAL TRIALS, COUPLED WITH THE CURRENT DES LITERATURE AND THE SPECIFIC NEEDS OF INDIVIDUAL PATIENTS TO DETERMINE THE SPECIFIC ANTIPLATELET/ANTICOAGULATION REGIMEN TO BE USED FOR THEIR PATIENTS IN GENERAL PRACTICE. IT IS VERY IMPORTANT THAT THE PATIENT IS COMPLIANT WITH THE POST PROCEDURAL ANTIPLATELET RECOMMENDATIONS. PREMATURE DISCONTINUATION OF PRESCRIBED ANTIPLATELET MEDICATION COULD RESULT IN A HIGHER RISK OF THROMBOSIS, MYOCARDIAL INFARCTION OR DEATH, PATIENTS WHO REQUIRE PREMATURE DISCONTINUATION OF ANTIPLATELET THERAPY SECONDARY TO SIGNIFICANT ACTIVE BLEEDING, SHOULD BE MONITORED CAREFULLY FOR CARDIAC EVENTS AND, ONCE STABILIZED, HAVE THEIR ANTIPLATELET THERAPY RESTARTED AS SOON AS POSSIBLE PER THE DISCRETION OF THEIR TREATING PHYSICIANS. IN THIS CASE, IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL (Q.C.) AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEFT ANTERIOR DESCENDING (LAD) PROXIMAL TO A DISTAL DIFFUSE LESION WAS 90-98% STENOSED. THE LEFT CIRCUMFLEX (LCX) OSTIUM LESION DIAGONAL TO THE OBTUSE MARGINAL (OM) 3 BIFURCATION LESION WAS 90% STENOSED. THE LAD WAS APPROACHED BY A NON-ABBOTT GUIDING CATHETER AND A NON-ABBOTT GUIDE WIRE CROSSED THE LESION SMOOTHLY. THE LAD WAS DILATED DISTAL TO PROXIMAL WITH TWO NON-ABBOTT BALLOONS AT 8-10 ATMOSPHERES (ATM) AND THERE WAS SIGNIFICANT RESIDUAL STENOSIS. A XIENCE V 2.5X28 AND A XIENCE V 2.5X23 WAS DEPLOYED TO THE LAD DISTAL TO MIDDLE. A NON-ABBOTT 2.75X20 BALLOON CATHETER WAS INFLATED UP TO 10 ATM IN THE LAD PROXIMAL AND A XIENCE V 2.75X23 WAS DEPLOYED IN THE LAD PROXIMAL TO MID UP TO 12 ATM AND TIMI FLOW WAS 3. THE LCX WAS APPROACHED WITH A FIELDER GUIDE AND IT CROSSED THE LESION SMOOTHLY. A NON-ABBOTT 2.5 BALLOON CATHETER WAS DILATED AND A XIENCE V 2.5X18 WAS DEPLOYED TO THE OSTIUM UP TO 12 ATM. HYPOTENSION AND THEN BRADYCARDIA FOLLOWED AND DOPAMINE WAS INFUSED. CARDIO PULMONARY RESUSCITATION (CPR) WAS PERFORMED DUE TO ASYSTOLE. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED. THE PATIENT'S BLOOD PRESSURE WAS RECOVERED TRANSIENTLY. EMERGENT EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) WAS IMPLANTED BY A CARDIO SURGERY PHYSICIAN; HOWEVER, THERE WAS NO RESPONSE TO THE ASYSTOLE WITH CPR FOR TWO (2) HOURS AND THE PATIENT DIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 0012841

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death INFLATION: 20/30 DOLPHIN| STENT: 2.5X23 XIENCE V (1009527-23/(B)(4))| GUIDE WIRE: RINATO, FIELDER| SHEATH: TERUMO| 2.75X23 XIENCE V (1009528-23/(B)(4))| DIL CATH: SPRINTER 2.5X20, 2.5X30| GUIDE CATH: XB 3.5 7F| 2.5X28 XIENCE V (1009527-28/(B)(4))