BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923433 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02712
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    May 20, 2009
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 CUSTOMER REPORTED THE DEVICE REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED MYOCARDIAL INFARCTION (MI) IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE EVENT. IN THIS CASE, THE PATIENT WAS TREATED WITH MEDICATION (ASPIRIN AND CLOPIDOGREL). 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 AND THE TREATMENTS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. NO. 2 PROMUS #1009539-12B, LOT#8101561,SER # UNK IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL TRIAL THAT THE TARGET LESION WAS LOCATED IN THE 1ST DIAGONAL WITH 90% STENOSIS. PREDILATATION WAS PERFORMED PRIOR TO PLACEMENT OF THE 2.5 X 28 MM STUDY STENT. FOLLOWING POST-DILATATION, EDGE STENOSIS WAS OBSERVED ON THE DISTAL PORTION AND WAS THEREFORE COVERED WITH A 2.50 X 12 MM STUDY STENT. LESION STENOSIS AFTER STENTING WAS 0%. ON (B)(6) 2009, 1 DAY POST INDEX PROCEDURE, CARDIAC ENZYMES WERE NOTED AS BEING ELEVATED, WHICH IS CONSISTENT WITH THE PROTOCOL DEFINITION OF AN MYOCARDIAL INFARCTION(MI). NO ACTION WAS TAKEN TO TREAT THIS EVENT. THE PATIENT WAS DISCHARGED (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) 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 8100961

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability