BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1850841 · Received September 28, 2010

    Report

    Report Number
    2024168-2010-02028
    Event Type
    Injury
    Date Received
    September 28, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 3, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE PT. A F/U REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE RX PROMUS (PART 1009540-15B, LOT 9120341) IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED A PROMUS 3.0 X 28 AND PROMUS 2.75 X 15 WERE DEPLOYED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PROMUS 3.0 X 28 WAS DEPLOYED WITHIN THE DISTAL PORTION OF THE PROXIMAL LAD AND THE PROMUS 2.75 X 15 WAS DEPLOYED IN THE PROXIMAL PORTION OF THE DISTAL LAD. INTRAVASCULAR ULTRA SOUND (IVUS) WAS PERFORMED AND 75% TO 90% STENOSIS REMAINED IN THE PROXIMAL LESION AND FURTHER TREATMENT WAS SCHEDULED. AFTER THE STENTS WERE DEPLOYED THERE WERE NO ABNORMALITIES IN THE PT CONDITION AND THE PT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. ON (B)(6) 2010, AFTER THE PT WAS DISCHARGED FROM THE HOSPITAL THE PT HAD DISCOMFORT IN THE CHEST, ST SEGMENT ELEVATION WAS CONFIRMED AND THE PT WAS SENT FOR CORONARY ANGIOGRAPHY (CAG) AND IN-STENT THROMBOSIS (ISR) OF THE LAD WAS OBSERVED. THROMBECTOMY WAS PERFORMED AND ANOTHER STENT WAS DEPLOYED TO TREAT THE ISR AND THE PT RECOVERED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9101241

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIL CATH: PRE: SEMI-COMPLIANT BALLOON 2.5 X 15| RX PROMUS (P.N. 1009540-15B, LOT# 9120341)| POST: NON-COMPLIANT BALLOON 3.0 X 15