BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2192678 · Received August 5, 2011

    Report

    Report Number
    2024168-2011-05530
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    February 15, 2011
    Report Date
    July 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, ARRHYTHMIA (INCLUDING BRADYCARDIA), HYPOTENSION AND HYPERSENSITIVITY ARE LISTED IN THE INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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 THE LESION TREATED WITH THE PROMUS STENT WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS. IMMEDIATELY POST PROCEDURE, ON THE WAY INTO THE RECOVERY ROOM, THE PATIENT BEGAN EXPERIENCING CHEST PAIN AND PAIN IN THE LEFT ARM DOWN TO HER HAND. POST PROCEDURE IN THE RECOVERY ROOM, THE PATIENT'S HEART RATE DROPPED TO LESS THAN 30. ON FOLLOW UP CATHERIZATION, THE PHYSICIAN NOTED NO ISSUE WITH THE PROMUS STENT. THE PHYSICIAN FELT THAT THE PATIENT WAS POSSIBLY ALLERGIC TO SOMETHING IN THE STENT. DURING CARDIAC REHAB APPOINTMENTS, IT HAD ALSO BEEN NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS HIGH, THEREFORE ADDITIONAL MEDICATIONS WERE ADDED (UNSPECIFIED). NO ADVERSE PATIENT SEQUELA WERE REPORTED. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention