BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2103183 · Received May 25, 2011

    Report

    Report Number
    2024168-2011-03698
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. MYOCARDIAL INFARCTION, OCCLUSION, 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, COULD NOT 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) 2008, A 3.0X18 PROMUS STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT WAS DISCHARGED WITH 18 MONTHS OF PLAVIX PRESCRIBED. IN (B)(6) 2010, THE PHYSICIAN DISCONTINUED THE MEDICATION. ON (B)(6) 2011, THE PATIENT PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. ANGIOGRAPHY REVEALED IN-STENT THROMBOSIS AND COMPLETE OCCLUSION. MULTIPLE NON-ABBOTT DILATATION CATHETERS WERE USED TO SUCCESSFULLY TREAT THE THROMBOSIS/OCCLUSION. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED GOOD RESULTS AND GOOD STENT APPOSITION. THE PATIENT IS REPORTED AS DOING FINE. THOUGH REQUESTED, 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 8072361

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R| S