BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1932219 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02802
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    June 30, 2009
    Report Date
    November 22, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED OCCLUSION IS LISTED IN THE INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING. THE 3.0 X 12 MM PROMUS RX (B)(4), IS BEING FILED UNDER A SEPARATE MFR#.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL TRIAL THAT THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD)(CASS SITE 13) WITH 95% STENOSIS, A LENGTH OF 24 MM, AND A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, PLACEMENT OF A 3.0 X 28 MM AND A 3.0 X 12 MM STUDY STENT, AND POST-DILATATION WITH 0% RESIDUAL STENOSIS. AFTER POST DILATATION OF THE STUDY STENT WAS PERFORMED, AN ABRUPT CLOSURE OF THE VESSEL OCCURRED; HOWEVER, THE SYMPTOMS WERE TRANSIENT. TIMI 3 FLOW RESTORED. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009, ON ASPIRIN AND CLOPIDOGREL. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    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 8100761

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Disability STENT: 3.0 X 12 MM PROMUS RX (B)(4)