BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2210833 · Received August 12, 2011

    Report

    Report Number
    2024168-2011-05713
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 15, 2011
    Report Date
    July 22, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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. THE PROMUS 3.0 X 12 IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED RESTENOSIS IS A KNOWN ADVERSE EVENT LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT A STENTING PROCEDURE IN WHICH FIVE PROMUS STENTS WERE IMPLANTED IN THE PROXIMAL AND MID RIGHT CORONARY ARTERY (RCA). DURING AN INTERVENTIONAL PROCEDURE FOR SUBACUTE CORONARY PERFORATION ON (B)(6) 2011, REVASCULARIZATION WAS PERFORMED IN THE MID RIGHT CORONARY ARTERY (MRCA) FOR 50% INSTENT RESTENOSIS IN THE 3.0 X 12 MM AND THE 3.0 X 18 MM PROMUS STENTS. THE POST PROCEDURE STENOSIS WAS 0% RESIDUAL AND NORMAL FLOW IN THE MRCA. THE PATIENT'S CONDITION RESOLVED. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION 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 52 YR Required Intervention PROMUS 3.5 X 18, 3.5 X 18, 3.5 X 8, AND 3.0 X 12