BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2143706 · Received June 29, 2011

    Report

    Report Number
    2024168-2011-04560
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    March 31, 2011
    Report Date
    June 8, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, ISCHEMIA, AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. 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. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE OTHER PROMUS HAS BEEN FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    REPORTEDLY ON (B)(6) 2010, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF THREE PROMUS STENTS (1-3.0X28 AND 2-3.5X28 MM) TO THE PROXIMAL RIGHT CORONARY ARTERY (RCA) DUE TO STABLE ANGINA, A POSITIVE STRESS TEST, POST ST ELEVATION MYOCARDIAL INFARCTION (STEMI) AND DYSPNEA. THE PATIENT RECEIVED A PERI-PROCEDURAL LOADING DOSE OF STUDY MEDICATION CLOPIDOGREL, 300 MG. POST-PROCEDURE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. ON (B)(6) 2010, THE PATIENT BEGAN 75 MG CLOPIDOGREL DOSING AND WAS DISCHARGED FROM THE HOSPITAL. ADDITIONALLY, THE PATIENT BEGAN TAKING 325 MG ASPIRIN, HOWEVER, THE START DATE IS UNKNOWN. ON (B)(6) 2011, THE PATIENT EXPERIENCED ANGINA AND HAD A POSITIVE STRESS TEST (ISCHEMIA) WITH SYMPTOMS OF CORONARY ARTERY DISEASE (CAD). THE PATIENT WAS ADMITTED FOR AN ELECTIVE CATHETERIZATION. A DIAGNOSTIC CARDIAC CATHETERIZATION SHOWED A COMPLEX 95% RCA (PROXIMAL) LESION. THE PATIENT UNDERWENT A SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION FOR IN-STENT RESTENOSIS OF THE TWO PREVIOUSLY PLACED 3.5 X 28MM PROMUS STENTS LOCATED IN THE RCA WITH ONE NON-ABBOTT 3.5X28 DRUG ELUTING STENT. THE MID RCA WAS IDENTIFIED TO HAVE A 70% DIAMETER STENOSIS WHICH WAS PRE-DILATED AND STENTED WITH A 3.5 X 28 MM DES STENT. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE EVENT WAS REPORTED AS CONTINUING AT THE TIME OF DISCHARGE. NO ADDITIONAL INFORMATION WAS PROVIDED. IN THE OPINION OF THE INVESTIGATOR, THE EVENT WAS MODERATE IN INTENSITY, NOT RELATED TO STUDY DRUG, DEFINITELY RELATED TO STUDY DEVICE, AND NOT RELATED TO STUDY PROCEDURE.

    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 0043041

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R STENT: PROMUS 3.5X28