BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2179576 · Received July 27, 2011

    Report

    Report Number
    2024168-2011-05243
    Event Type
    Death
    Date Received
    July 27, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 30, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CINE OF THE CASE WAS RECEIVED AND REVIEWED BY A CLINICAL ANALYST. THERE ARE LESIONS IN ALL THREE MAJOR VESSELS. THE 2ND OBTUSE MARGINAL (OM) IS OCCLUDED. A WIRE IS POSITIONED IN THE LEFT CIRCUMFLEX (LCX) INTO THE 2ND MARGINAL. THERE ARE ALSO SEVERAL LUCENCIES PRESENT THAT SUGGEST THROMBUS. A SECOND WIRE IS PLACED IN THE 1ST OM. A LONG STENT IS POSITIONED FROM THE PROXIMAL LCX INTO THE PROXIMAL/MID 2ND OM. DURING INFLATION OF THE STENT DELIVERY SYSTEM THE STENT/BALLOON DOES NOT FULLY EXPAND IN TWO LOCATIONS (PROX STENT AND MID STENT). A WIRE IS THEN POSITIONED IN THE RIGHT CORONARY ARTERY (RCA) AND A LONG STENT IS DEPLOYED IN THE PROXIMAL TO MID VESSEL. THE LEFT CORONARY ARTERY (LCA) IS NEXT IMAGED. (IT IS ASSUMED THAT THIS IS THE INITIATION OF THE 2ND PROCEDURE) THE LCX STENT IS OPEN AND THERE IS GOOD DISTAL FLOW. GUIDE WIRES ARE POSITIONED IN THE LAD AND DIAGONAL. A LONG STENT IS DEPLOYED IN THE PROXIMAL TO MID LCA. A SECOND STENT IS THEN DEPLOYED IN THE OSTIO-PROXIMAL LAD. FINAL RESULTS SHOW GOOD FLOW IN THE LCA. IT WAS CONCLUDED THAT THERE WERE STENTS DEPLOYED IN ALL THE VESSELS, AS REPORTED IN THE DESCRIPTION, ALTHOUGH THE CAUSE OF THE PATIENT ARREST COULD NOT BE IDENTIFIED OR CONFIRMED THROUGH THESE IMAGES. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ARRHYTHMIAS INCLUDING BRADYCARDIA, HYPOTENSION, RESPIRATORY FAILURE/ARREST, AND DEATH, AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT 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. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH TRIPLE VESSEL CORONARY ARTERY DISEASE OF THE LEFT CIRCUMFLEX (LCX), THE RIGHT CORONARY ARTERY (RCA), AND THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PATIENT ALSO HAD ELEVATED CREATININE LEVELS AND IT WAS DECIDED TO PERFORM THE PROCEDURE IN TWO STAGES, THE FIRST PROCEDURE ON (B)(6) AND THE SECOND PROCEDURE ON THE (B)(6). ON THE (B)(6) THE CULPRIT VESSEL, THE PROXIMAL TO MID LCX, WAS TREATED WITH A XIENCE PRIME 3.5 X 38 MM, AND THE OSTIO PROXIMAL RCA WAS TREATED WITH A XIENCE PRIME 3.5 X 33 MM. DURING THE SECOND PROCEDURE ON THE (B)(6), THE LAD WAS TREATED IN AN OVERLAPPING FASHION WITH A XIENCE PRIME 3.0 X 38 MM AND XIENCE V 3.0 X 18 MM. EXCELLENT FLOW WAS ATTAINED IN ALL THREE VESSELS: LCX, RCA AND LAD. THE SAME NIGHT THE PATIENT DEVELOPED BRADYCARDIA AND WAS INTUBATED IMMEDIATELY AND STARTED ON IONOTROPES AND PUT ON VENTILATOR SUPPORT. ON (B)(6) 2011 AT 02:00 AM, THE PATIENTS BLOOD PRESSURE FELL DOWN TO 70; INJECTABLE ATROPINE AND INJECTABLE ADRENALINE WERE CONTINUED; HOWEVER, THE PATIENT WENT INTO BRADYCARDIA FOLLOWED BY CARDIAC ARREST. CPR WAS STARTED AND THE PATIENT WAS REVIVED; HOWEVER, THE PATIENT WENT INTO BRADYCARDIA AND CARDIAC ARREST AGAIN, AND COULD NOT BE REVIVED AND WAS DECLARED DEAD ON (B)(6) 2011 AT 02:40 AM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0101341

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death STENT: XIENCE PRIME 3.5 X 38, 3.5 X 33, 3.0 X 38