BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1930732 · Received December 16, 2010

    Report

    Report Number
    2024168-2010-02786
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    May 10, 2010
    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
    PL
    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 WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS ARE 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 277 DAYS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH CHEST PAIN AND DIAGNOSED WITH UNSTABLE ANGINA. THE TARGET LESION WAS A PRE-DILATATED FIRST OBTUSE MARGINAL (OM) WITH 70% STENOSIS, A LENGTH OF 14 MM, AND A REFERENCE VESSEL DIAMETER OF 2.50 MM, A 2.50X18 MM PROMUS STENT WAS PLACED AND POST-DILATATION WITH 0% RESIDUAL STENOSIS. ON (B)(6) 2010 CORONARY ANGIOGRAPHY REVEALED: LEFT ANTERIOR DESCENDING (LAD) ARTERY 80% PROXIMAL IN-STENT RESTENOSIS, AND TARGET VESSEL LEFT CIRCUMFLEX 99% IN-STENT RESTENOSIS. THE FIRST OM WAS TREATED WITH A 2.5 X 15 MM XIENCE STENT WITH 0% RESIDUAL STENOSIS. THE LAD WAS TREATED WITH A 3.5 X 12 MM XIENCE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2010 ON ASPIRIN AND CLOPIDOGREL. THOUGH REQUESTED, 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 8093061

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R