BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2132996 · Received June 17, 2011

    Report

    Report Number
    2024168-2011-04336
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PORTION OF THE EVENT DESCRIPTION WAS INADVERTENTLY OMITTED FROM THE INITIAL REPORT. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ARRHYTHMIA, CARDIAC ARREST, DEATH EKG/ECG CHANGES, CARDIAC ENZYME ELEVATION, HYPOTENSION, INFECTION, STENOSIS AND ANGINA ARE LISTED IN THE PROMUS INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, 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. STENTS: NOBORI 2.75 X 18 MM, 2.5 X 23 RX PROMUS; GUIDE WIRE: XTREME GUIDE WIRE. THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE XIENCE V IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, A 2.5 X 23 MM PROMUS STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING (LAD) AND A 2.5 X 15 MM PROMUS STENT WAS IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX). ON (B)(6) 2011, A 3.0 X 15 MM XIENCE V STENT WAS IMPLANTED DUE TO AN IN-STENT RESTENOSIS AND FRACTURE OF A NON-ABBOTT STENT IN THE RIGHT CORONARY ARTERY (RCA). IT WAS CONFIRMED THAT THE STENT HAD GOOD EXPANSION BASED ON ANGIOGRAPHY AND INTRAVASCULAR ULTRASOUND AND THE PROCEDURE WAS COMPLETED. REPORTEDLY, THE PATIENT HAD STOPPED DUAL ANTIPLATELET THERAPY SINCE (B)(6) 2011, DUE TO A SCHEDULED OPERATION FOR SHUNT OCCLUSION OF LEFT UPPER EXTREMITY (KIDNEY). ON (B)(6) 2011, THE PATIENT SUDDENLY WENT INTO SHOCK IN THE MEDICAL WARD AND RECOVERED BUT THE PATIENT WENT INTO SHOCK AGAIN AND RECOVERED IN A FEW MINUTES BUT THERE WERE CONFIRMED ELECTROCARDIOGRAM CHANGES AND THE PATIENT PRESENTED WITH CHEST PAIN. A CARDIOVASCULAR PHYSICIAN WAS CALLED AND THE PATIENT WAS IN SHOCK DURING PREPARATION FOR TRANSPORTATION TO THE CARDIAC CARE UNIT. AN EMERGENCY CATHETERIZATION WAS PERFORMED SINCE ELEVATED CARDIAC ENZYMES WERE CONFIRMED. AS A RESULT, THE RCA HAD IN-STENT RESTENOSIS AND POOR BLOOD FLOW. THE LEFT CIRCUMFLEX HAD 100% STENOSIS. AT THIS TIME THE PATIENT WAS IN SHOCK AGAIN, SO A INTRAAORTIC BALLOON PUMP (IABP) WAS INSERTED AND THE PATIENT WAS INTUBATED. A TEMPORARY PACEMAKER WAS ALSO INSERTED. INTERVENTION WAS STARTED ON THE RCA WITH DILATATION AND BLOOD FLOW IMPROVED TO TIMI 3. THEN THE CX WAS TREATED. SOON AFTER, BLOOD FLOW OF LCX AND RCA SHUT DOWN AND THE PATIENT WENT INTO SHOCK.

    Description of Event or Problem · 1

    AFTER REVIEWING THE AMOUNT OF CONTRAST AGENT AND PROCEDURE TIME, INTERVENTION WAS CONDUCTED ON THE RIGHT CORONARY ARTERY (RCA) MAIN ONLY. A SWAN-GANZ CATHETER WAS INSERTED IN THE PATIENT AND WAS RETURNED TO THE CARDIAC CARE UNIT. THE PATIENT CONTINUED TO REPEAT A STATE OF SHOCK AND MAINTAINED BLOOD PRESSURE WITH REHYDRATION. ON (B)(6) 2011, THE INTRA-AORTIC BALLOON PUMP (IABP) WAS REMOVED FROM THE PATIENT BECAUSE OF IMPROVING HEMODYNAMIC COMPROMISE. ON (B)(6) 2011, CORONARY ANGIOGRAPHY WAS PERFORMED. AS A RESULT, THE RCA, WHERE THE XIENCE HAD BEEN PLACED HAD STENOSIS AND THE LEFT CIRCUMFLEX (LCX), WHERE THE PROMUS HAD BEEN PLACED, WAS TOTALLY OCCLUDED. ON (B)(6) 2011, INTERVENTION WAS PERFORMED TO THE LCX AND A NON-ABBOTT STENT WAS IMPLANTED AND THE STENOSIS WAS REDUCED TO 0%. SEDATION WAS THEN STOPPED AND THE PATIENT WAS REMOVED FROM THE VENTILATOR. ON (B)(6) 2011, THE PATIENT GOT A FEVER OF 39 DEGREES AND (B)(6) WAS DETECTED FROM BLOOD CULTURE AND THE TRICUSPID VALVE HAD VEGETATION. TREATMENT WAS IMMEDIATELY STARTED, BUT THE PATIENT WENT INTO SHOCK AT NIGHT AND STARTED TO BREATH CHEMISCHER. IN SPITE OF TREATMENT, HEMODYNAMIC STATUS WAS UNSTABLE AND LEVEL OF CONSCIOUSNESS DEPRESSED AND THERE WAS CONFIRMED RESPIRATORY ELIMINATION. ON (B)(6) 2011, A WHOLE-BODY CT SCANNING WAS PERFORMED AND THE PATIENT HAD HYPOXIC ENCEPHALOPATHY IN THE HEAD. ON (B)(6) 2011, THE PATIENTS CONDITION DETERIORATED RAPIDLY AND THE PATIENT EXPIRED. THE PHYSICIAN COMMENTED THAT THERE WAS NO RELATIONSHIP BETWEEN THE NON-ABBOTT STENT AND THE DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0083142

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death