BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1967293 · Received January 21, 2011

    Report

    Report Number
    2024168-2011-00421
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 27, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. RASH/HYPERSENSITIVITY/ALLERGIC REACTION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROMUS STENT WAS RECENTLY IMPLANTED IN A PATIENT. THE PATIENT SUBSEQUENTLY DEVELOPED A RASH AND THE PATIENT WAS CONCERNED THAT THE RASH WAS RELATED TO THE RECENTLY IMPLANTED STENT. THE PHYSICIAN THOUGHT THAT THE RASH WAS MORE LIKELY TO BE RELATED TO CONTRAST USED DURING THE PROCEDURE, OR TO ONE OF THE PATIENT'S MEDICATIONS. HE HAD INITIALLY PRESCRIBED CLOPIDOGREL, BUT SWITCHED THAT TO PRASUGREL AFTER THE PATIENT DEVELOPED THE RASH. THE RASH DID NOT SEEM TO BE IMPROVING, SO THE PHYSICIAN ALSO STARTED THE PATIENT ON A COURSE OF ORAL STEROIDS. THE RASH APPEARS TO BE RESOLVING WITH THIS TREATMENT. 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