BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2559050 · Received May 3, 2012

    Report

    Report Number
    2024168-2012-02852
    Event Type
    Injury
    Date Received
    May 3, 2012
    Date of Event
    March 25, 2012
    Report Date
    April 9, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REPORTED PATIENT EFFECTS OF ANGINA AND STENOSIS/RESTENOSIS ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) 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. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN AN IN-STENT RESTENOSED LESION. IT SHOULD BE NOTED THAT THE IFU STATES, PROMUS IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. IN THIS CASE, IT IS UNKNOWN IF THE REPORTED IFU DEVIATION DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2011 TO TREAT THE 95% STENOSED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD), A 3.5 X 24 MM NON-ABBOTT STENT WAS DEPLOYED FOR TREATMENT OF THE STENOSIS. THE PROCEDURE LEFT A 9% RESIDUAL STENOSIS IN THE LESION AND THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2011, THE PATIENT UNDERWENT REVASCULARIZATION OF THE PROXIMAL LAD FOR TREATMENT OF RESTENOSIS IN THE NON-ABBOTT STENT AND A 3.0 X 23 MM PROMUS STENT WAS IMPLANTED OVERLAPPING THE DISTAL EDGE OF THE NON-ABBOTT STENT. ON (B)(6) 2012, 416 DAYS POST PROCEDURE, THE PATIENT WAS EXPERIENCING ANGINA AND WAS REHOSPITALIZED. ANGIOGRAPHY REVEALED THE PREVIOUSLY DEPLOYED NON-ABBOTT STENT WAS WIDELY PATENT FROM MID TO DISTAL; HOWEVER, REVEALED PROXIMAL EDGE AND FOCAL (70%) IN-STENT RESTENOSIS OF THE NON-ABBOTT STENT AND EDGE STENT RESTENOSIS OF THE PROMUS STENT, WHICH WAS TREATED WITH THE PLACEMENT OF A 3.5 X 28 MM XIENCE V STENT. ANGIOGRAPHY NOTED LESS THAN A 10% RESIDUAL STENOSIS. NO OTHER 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 0042841

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R