BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2069938 · Received April 26, 2011

    Report

    Report Number
    2024168-2011-02944
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT THE PROCEDURE ON (B)(6) 2009 WAS TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A 90% STENOSIS. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5 X 12 MM PROMUS STENT. POST-DILATATION WAS PERFORMED WITH END RESULTS OF 19% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. THE SITE REPORTED AN EVENT OF CARDIAC CHEST PAIN WITH AN ONSET OF (B)(6) 2011. THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2011, 567 DAYS POST INDEX PROCEDURE, AND TREATED WITH REVASCULARIZATION TO THE TARGET AND NON-TARGET VESSEL. THE TARGET LESION LOCATED IN THE MID LAD HAD AN 80% STENOSIS AND WAS TREATED WITH DRUG ELUTING STENT PLACEMENT WITH 0% RESIDUAL STENOSIS. THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2011. 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 8101561

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R