BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2022380 · Received March 17, 2011

    Report

    Report Number
    2024168-2011-01790
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 21, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THERE WAS NO REPORTED PRODUCT DEFICIENCY. HYPERSENSITIVITY/ALLERGIC REACTION AND PAIN ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. 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. THE 2.5 X 15 MM PROMUS IS BEING FILED UNDER A SEPARATE MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TWO PROCEDURES DURING WHICH SHE HAD TWO PROMUS STENTS IMPLANTED. THE FIRST PROCEDURE ON (B)(6) 2010, WAS TO TREAT THE RIGHT CORONARY ARTERY. THE SECOND PROCEDURE ON (B)(6) 2010, WAS TO TREAT THE POSTERIOR DESCENDING ARTERY. APPROXIMATELY ONE MONTH AGO, THE PATIENTS NECK BROKE OUT IN A RASH FROM A NECKLACE THAT SHE HAS PREVIOUSLY WORN OVER THE YEARS WITHOUT ANY PROBLEM. SHE ALSO STATED THAT SHE HAS HAD AN ITCHY BACK, BETWEEN HER SHOULDER BLADES FOR THE LAST MONTH OR SO. HER CARDIOLOGIST DIAGNOSED IT AS DRY SKIN; HOWEVER, SHE DOES NOT BELIEVE THIS IS THE CASE. THE PATIENT HAS BEEN TREATING IT WITH LOTION AS HER PHYSICIAN DID NOT PROVIDE ANY TREATMENT. SHE IS ON MEDICATIONS THAT CAN CAUSE RASHES; HOWEVER, SHE FEELS THE RASH WOULD BE ALL OVER HER BODY AND NOT JUST IN ONE SPOT IN THE MIDDLE OF HER BACK. HER BACK IS WEAK AND PAINFUL AND SHE CAN ONLY TREAD AT THE GYM NOW. 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 0043041

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other STENT: 2.5X15 MM PROMUS