BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2110540 · Received June 1, 2011

    Report

    Report Number
    2024168-2011-03813
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    September 17, 2010
    Report Date
    May 9, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. MYOCARDIAL INFARCTION AND THROMBOSIS ARE KNOWN ADVERSE EVENTS 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. 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 THAT ON (B)(6)2010, AT OUTLYING FACILITY FOR MI, PT TREATED WITH 2.5X15 PROMUS OTW TO PROXIMAL LAD. DISCHARGED ON ASA AND PLAVIX, BUT HAS A HISTORY OF NOT BEING FULLY COMPLIANT WITH MEDICINES. ON (B)(6) 2010, TRANSFERRED TO OUR FACILITY WITH NONSTEMI. FILMS REVEAL 100% OCCLUSION AT SITE OF PREVIOUSLY PLACED STENT WITH THROMBUS. A 2.5X15 APEX FOR MULTIPLE INFLATIONS. THROMBECTOMY PERFORMED. A 3.0X15 APEX TO FURTHER DILATE WITH GOOD ANGIOGRAPHIC RESULTS. INTEGRILIN DRIP TO CONTINUE FOR 12 HOURS. DISCHARGED ON ASA AND PRASUGREL. 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 9070861

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R| S