BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1672086 · Received April 30, 2010

    Report

    Report Number
    2024168-2010-00898
    Event Type
    Injury
    Date Received
    April 30, 2010
    Date of Event
    November 9, 2009
    Report Date
    April 6, 2009
    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
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). THE UNK PROMUS, PROMUS 2.5X12MM (P.N. 1009539-12B, LOT# 8120941), PROMUS 2.5X12MM (P.N. 1009539-12B, LOT# 9040661), ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. RENAL FAILURE/INSUFFICIENCY AND PAIN ARE RECOGNIZED AS NO FAULT COMPLICATIONS IN THE NO FAULT RISK ASSESSMENT. ADDITIONALLY, RENAL FAILURE/INSUFFICIENCY IS LISTED AS A KNOWN ADVERSE EVENT OF CORONARY STENTING AND PAIN AS A KNOWN ADVERSE EVENT OF DAILY ORAL ADMINISTRATION OF EVEROLIMUS IN THE PROMUS IFU. HOWEVER, IT IS ALSO POSSIBLE THAT THE REPORTED PATIENT EFFECTS ARE RELATED TO OTHER HEALTH CONDITIONS OR MEDICATION. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP, IF ANY, TO THE DEVICES CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    DEVICE ISSUE: NONE. ADVERSE EVENT: PAIN AND RENAL FAILURE. TIME OF ADVERSE EVENT: AFTER STENT IMPLANTATION. IT WAS REPORTED THAT A PATIENT EXPERIENCED MUSCLE PAIN AND JOINT PAIN AFTER THE FIRST PROMUS STENT WAS IMPLANTED. WITH THE IMPLANTATION OF 3 ADDITIONAL PROMUS STENTS, ON (B) (6) 2009, THE SYMPTOMS HAVE WORSENED. REPORTEDLY, SINCE THE STENTS WERE IMPLANTED, THE PATIENT'S KIDNEY FUNCTION HAS DECLINED INCLUDING A DECREASE IN "GFR TO 43" AND "CREATINE CLEARANCE DOWN TO 1/37". THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 9050861

    Patients

    Seq Age Sex Outcome Treatment
    1 Other PROMUS 2.5X12MM (P.N. 1009539-12B, LOT# 9040661)| UNK PROMUS, PROMUS 2.5X12MM (P.N. 1009539-12B,| LOT# 8120941),