BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1926161 · Received December 14, 2010

    Report

    Report Number
    2024168-2010-02735
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    August 10, 2009
    Report Date
    November 19, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. DISSECTION IS A KNOWN ADVERSE EVENT 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.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT THE TARGET LESION WAS LOCATED IN THE DISTAL LCX WITH 90% STENOSIS. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.0 X 18 MM STUDY STENT. A 3.0 X 12 MM STUDY STENT WAS PLACED DUE TO INADEQUATE LESION COVERAGE, FOLLOWED BY POST-DILATATION WITH 0% RESIDUAL STENOSIS. PER CORE LAB BASELINE INDEX ANGIO RESULTS, DATED (B)(6) 2009: A SECOND STENT WAS DEPLOYED FOR A DISTAL EDGE DISSECTION. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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 8100361

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention CLOPIDOGREL, ASPIRIN