BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1612212 · Received February 17, 2010

    Report

    Report Number
    2024168-2010-00297
    Event Type
    Injury
    Date Received
    February 17, 2010
    Date of Event
    November 27, 2009
    Report Date
    January 25, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) FATIGUE. (B) (4). THE SECOND PROMUS RX 2.5 X 08 MM (PART#1009539-08B/LOT#9033161) MENTIONED IS BEING FILED UNDER THE SAME MANUFACTURER NUMBER.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: ALLERGIC REACTION REQUIRING MEDICATIONS. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT DURING THE TWO TO THREE WEEKS POST IMPLANTATION OF TWO PROMUS STENTS IN AN UNSPECIFIED VESSEL, THE PATIENT COMPLAINED OF AN INABILITY TO EAT AND STOMACH PAIN. THE SYMPTOMS WERE DETERMINED TO BE DUE TO THE COMBINATION OF PRILOSEC AND PLAVIX. STOMACH PAIN EASED WITH THE DISCONTINUATION OF PRILOSEC. REPORTEDLY, THE PATIENT CONTINUES TO EXPERIENCE SLEEPLESSNESS, FATIGUE, INABILITY TO EAT OR SWALLOW, A FOUL TASTE IN THE MOUTH, CHEST PAIN, ARRHYTHMIAS, AND A SENSATION THAT BLOOD IS HOT WITH ACTIVITY. THE PATIENT HAS MANY ALLERGIES INCLUDING METAL ALLERGIES. THE PATIENT CONTINUES TO TAKE BENADRYL. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B) (4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE U.S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9071641

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROMUS RX 2.5 X 08MM: PART#1009539-08B/LOT#9033161