BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3038950 · Received April 5, 2013

    Report

    Report Number
    2024168-2013-02034
    Event Type
    Injury
    Date Received
    April 5, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, ARRHYTHMIA, DYSPNEA, FATIGUE, HYPOTENSION, NAUSEA, AND RESTENOSIS, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM 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, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, OR DESIGN. THE 3.5 X 18 MM PROMUS REFERENCED IN IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DUE TO UNSTABLE ANGINA, THE SUBJECT UNDERWENT THE INDEX PROCEDURE WITH THE DEPLOYMENT OF TWO DRUG ELUTING STENTS, BOTH TO THE FIRST OBTUSE MARGINAL BRANCH. POST PROCEDURE RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2010, THE SUBJECT WAS STARTED ON ASPIRIN 325MG. ON (B)(6) 2010, THE SUBJECT WAS DISCHARGED FROM THE INDEX HOSPITALIZATION. ON (B)(6) 2011, THE SUBJECT WAS RANDOMIZED TO CLOPIDOGREL OR PLACEBO, AND WAS ADMINISTERED THE FIRST DOSE ON (B)(6) 2011. ON (B)(6) 2013, 862 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH COMPLAINTS OF AN ONSET OF CHEST PAIN THAT STARTED THE WEEK BEFORE CHRISTMAS AND HAS INCREASED IN INTENSITY AND FREQUENCY. ALSO REPORTED WAS SUBSTERNAL CHEST PAIN RADIATING TO HIS BACK, BILATERAL SHOULDERS AND ARMS WHICH WAS MORE SEVERE THAN HIS TYPICAL ANGINA, INCREASING FATIGUE, DECREASED EXERCISE TOLERANCE, INCREASING DYSPNEA ON EXERTION, NAUSEA AND PRESYNCOPE AS WELL AS NOCTURNAL ANGINA AND PALPITATIONS. HE WAS TREATED WITH ASPIRIN, 1MG OF ATIVAN (LORAZEPAM) INTRAVENOUSLY, NITROGLYCERIN 400 MCG SPRAY X2. THE NITROGLYCERIN DID NOT RELIEVE HIS PAIN. A NITROGLYCERIN INFUSION WAS INITIATED; HOWEVER, IT WAS SUBSEQUENTLY DISCONTINUED DUE TO HYPOTENSION WITH SYSTOLIC PRESSURES IN THE 80S SYSTOLIC, 50S DIASTOLIC. THE OUTCOME OF THE EVENT IS REPORTED AS RECOVERED/RESOLVED AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED MEDWATCH REPORT, NEW INFORMATION WAS RECEIVED: BOTH THE 2.5 X 12 MM AND 3.5 X 18 MM PROMUS STENTS WERE OBSERVED TO HAVE MILD DIFFUSE IN-STENT RESTENOSIS THAT WAS LEFT UNTREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141611 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0043041

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R STENT: 3.5 X 18 MM PROMUS