BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2121527 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04131
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    March 3, 2011
    Report Date
    May 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    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 VASCULARS DRUG ELUTING STENT IN THE US. THE STENT REMAINS IN THE PATIENT. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2010, A 2.75X23 RX PROMUS STENT WAS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2011, THE PATIENT WAS SEEN FOR UNSTABLE ANGINA. ON (B)(6) 2011, CARDIAC CATHETERIZATION REVEALED THE RCA TO BE PATENT FROM THE PROXIMAL TO MID PORTION. THE MID TO DISTAL RCA REVEALED TWO FOCAL AREAS OF UP TO 90% DIAMETER STENOSIS AND 80% IN-STENT RESTENOSIS. THE CIRCUMFLEX ARTERY WAS VIEWED TO HAVE A VERY TORTUOUS ANGULATION AT GREATER THAN 90%, AND DEMONSTRATED MILD PLAQUE. THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS REVEALED TO BE CALCIFIED AT THE OSTIUM UP TO 40% STENOSIS, FOLLOWED BY A MILD DIFFUSE PROXIMAL DISEASE UP TO 40%. THE MID TO DISTAL LAD HAD MILD PLAQUE. ON (B)(6) 2011, A CORONARY ARTERY BYPASS GRAFT PROCEDURE WAS PERFORMED WITH A LIMA GRAFT TO THE LAD, A VEIN GRAFT TO THE POSTERIOR DESCENDING ARTERY, AND A VEIN GRAFT TO THE DIAGONAL BRANCH. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 ON CONTINUED ASPIRIN 81 MG DOSING. 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 50 YR Hospitalization| R