BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923396 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02701
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    March 11, 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
    NC, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND MYOCARDIAL INFARCTION (MI) ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IN THIS CASE, THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH MEDICATION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, 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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A TRIAL THAT THE INDEX PROCEDURE OCCURRED ON (B)(6) 2009. THE INDEX PROCEDURE WAS TO TREAT THE TARGET LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX), WHICH HAS A 90% STENOSIS. THE LESION LENGTH WAS 14 MM AND THE REFERENCE VESSEL DIAMETER WAS 2.5 MM. AFTER PRE-DILATATION, A PROMUS 2.5 X 18 WAS DEPLOYED IN THE LCX. THE PROCEDURE WAS COMPLETED WITH POST DILATATION. REPORTEDLY, THERE WERE NO PRODUCT ISSUES OR PATIENT EFFECTS NOTED DURING THE INDEX PROCEDURE. HOWEVER, THE FOLLOWING DAY ON (B)(6) 2010, THE SITE REPORTED AN EVENT OF PERI-PROCEDURAL MYOCARDIAL INFARCTION (MI). REPORTEDLY, THERE WAS NO TREATMENT FOR THE MI AND ON (B)(6) 2009 THE EVENT RESOLVED WITHOUT RESIDUAL AFFECTS AND THE PATIENT WAS DISCHARGE FROM THE HOSPITAL ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2009 THE PATIENT REPORTEDLY HAD NON-CARDIAC CHEST PAIN AND THE PATIENT WAS HOSPITALIZED AND TREATED WITH MEDICATION. THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON (B)(6) 2009.

    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 8093061

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| S UNSPECIFIED DILATATION CATHETER