BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2192922 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05540
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. THROMBOSIS IS KNOWN AS AN ADVERSE EVENT OF CORONARY STENTING IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT 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. 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. THE 3.0 X 15 MM PROMUS STENT IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, THE PROCEDURE WAS TO TREAT AN ACUTE MYOCARDIAL INFARCTION PATIENT WITH TOTAL OCCLUSION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.0 X 28 MM PROMUS STENT AND A 3.0 X 15 MM PROMUS STENT WERE IMPLANTED FOR TREATMENT. INTRAVASCULAR ULTRASOUND (IVUS) CONFIRMED THAT THE STENTS WERE FULLY EXPANDED. ON (B)(6) 2011 THROMBOSIS WAS OBSERVED IN THE PROXIMAL LAD; THEREFORE, A NON-ABBOTT STENT WAS USED FOR TREATMENT, OVERLAPPING THE PREVIOUSLY PLACED PROMUS STENT. THE OUTCOME WAS GOOD AND THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    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 1022161

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R STENT: PROMUS 3.0 X 15 MM