BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2475645 · Received March 2, 2012

    Report

    Report Number
    2024168-2012-01324
    Event Type
    Death
    Date Received
    March 2, 2012
    Date of Event
    July 30, 2011
    Report Date
    February 6, 2012
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF CARDIAC ARREST, RESPIRATORY DISTRESS/COMPROMISE, THROMBOSIS, AND DEATH ARE LISTED IN THE (B)(4) PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS. 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. THE XIENCE STENTS REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, AFTER PREDILATATION WAS PERFORMED ON THE LESIONS, THREE NON-ABBOTT STENTS WERE IMPLANTED IN LESIONS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), THE PROXIMAL LEFT CIRCUMFLEX (LCX) AND THE DISTAL LCX. NO POST-DILATATION WAS PERFORMED; HOWEVER, GOOD EXPANSION AND BLOOD FLOW (TIMI FLOW3) WAS CONFIRMED WITH INTRAVASCULAR ULTRASOUND (IVUS), AND THE PROCEDURE WAS COMPLETED. THE RESIDUAL STENOSIS RATE OF THE THREE TREATED LESIONS WAS 0%, AND THERE WAS RESIDUAL STENOSIS WAS IDENTIFIED IN THE LAD, DISTALLY. ON (B)(6) 2010, THE FINDINGS OF THE ELECTROCARDIOGRAM EXAMINATION AFTER THE PROCEDURE WERE CONSIDERED NORMAL. ON (B)(6) 2010, A PROMUS STENT WAS IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND TWO XIENCE V STENTS WERE IMPLANTED IN THE DISTAL RCA. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED. FOLLOW-UP VISITS ON (B)(6) 2011 CONFIRMED NO NEW ANGINA SYMPTOMS AND THE PATIENT WAS CONFIRMED TO BE TAKING ANTI-THROMBOTIC MEDICINES. ON (B)(6) 2011, THE PATIENT WAS FOUND DEAD WITH CARDIOPULMONARY ARREST AT HOME AND WAS TRANSFERRED TO THE HOSPITAL. AN INTRATRACHEAL INTUBATION WAS PERFORMED, ALONG WITH CPR, WITHOUT RESULTS. RESUSCITATION WAS STOPPED WITH THE FAMILY'S CONSENT. NO AUTOPSY WAS PERFORMED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death STENT: ENDEAVOR SPRINT AND XIENCE (X2)