BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1963062 · Received January 18, 2011

    Report

    Report Number
    2024168-2011-00371
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 21, 2010
    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. THERE WAS NO REPORTED PRODUCT DEFICIENCY. 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 OR DESIGN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONSUMER WAS READING THROUGH THE PATIENT GUIDE AND NOTICED THE CONTRAINDICATION RELATED TO NICKEL. SHE HAS A KNOWN ALLERGY TO NICKEL JEWELRY AND EXPERIENCES EXTERNAL DERMATOLOGICAL REACTIONS TO THE METAL. SHE IS UNAWARE OF ANY SPECIFIC REACTIONS TO THE NICKEL IN THE STENT, BUT WOULD NOT RECOGNIZE THE REACTIONS IF SHE HAD THEM. SHE HAS HAD SEVERAL STENTS IMPLANTED SINCE 2003, PRIOR TO THE (B)(6) 2010, IMPLANT; THE MOST RECENT STENT WAS PLACED IN 2006. SHE DID NOT PROVIDE DETAILS AS TO WHAT TYPE OF OTHER STENTS HAD BEEN IMPLANTED. SHE DID SAY THAT IN ALL CASES, PEOPLE WERE AWARE OF HER NICKEL ALLERGY AND SHE WEARS A MEDICAL ALERT BRACELET STATING THIS. SHE ALSO HAS SLIGHT HEAVINESS IN HER CHEST SINCE THE IMPLANT ON (B)(6) 2010. SHE DID NOT KNOW EXACTLY WHEN THE HEAVY FEELING SET IN. SHE HAS TRIED, UNSUCCESSFULLY, TO CONTACT HER PHYSICIAN. SHE ALSO CALLED THE NUMBER ON THE BACK OF THE PATIENT GUIDE, BUT GOT NOWHERE. 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 US.

    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 0070161

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other