BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1914591 · Received December 3, 2010

    Report

    Report Number
    2024168-2010-02596
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    August 19, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. ANGINA AND RESTENOSIS 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, DESIGN, OR LABELING. THE THIRD UNKNOWN PROMUS STENT IS BEING REPORTED UNDER A SEPARATE MEDWATCH REPORT NUMBER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUS MEDWATCH REPORT, INFORMATION WAS OBTAINED THAT THE DEVICE THAT WAS REPORTED WAS ONLY A TREATMENT STENT FOR A NEW LESION SITE IN A DIFFERENT ARTERY, 16 DAYS AFTER THE INDEX PROCEDURE. THEREFORE, THIS SHOULD NOT HAVE BEEN FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT ON (B)(6) 2010, DUE TO UNSTABLE ANGINA, THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH SUCCESSFUL DEPLOYMENT OF FOUR DRUG ELUTING STENTS. ONE WAS PLACED IN THE MID RIGHT CORONARY ARTERY CONDUIT SEGMENT AND ANOTHER WAS PLACED IN THE PROXIMAL CIRCUMFLEX ARTERY SEGMENT. THE FINAL TWO STENTS WERE PLACED IN THE FIRST LEFT POSTEROLATERAL BRANCH SEGMENT. RESIDUAL STENOSIS IN ALL THREE LESIONS WAS 0%. ON (B)(6) 2010, THE PATIENT RECEIVED A PERIPROCEDURAL LOADING DOSE OF 60.0 MG OF PRASUGREL. IN ADDITION, TO PREVENT DEEP VENOUS THROMBOSIS, HE WAS GIVEN HEPARIN AND ENOXAPARIN ON (B)(6) 2010. FOR HYPERLIPIDEMIA, THE PATIENT WAS STARTED ON ATORVASTATIN ON (B)(6) 2010. FOLLOWING THE PCI PROCEDURE, THE PATIENT WAS DISCHARGED HOME ON PROTOCOL REQUIRED DOSES OF PRASUGREL (10.0 MG) PLUS ASPIRIN (81 MG). THE PATIENT HAD PERSISTENT CHEST DISCOMFORT WHILE WALKING. ON (B)(6) 2010, HE WAS ADMITTED TO THE HOSPITAL WITH PROGRESSION OF CORONARY ARTERY DISEASE. HE UNDERWENT CARDIAC CATHETERIZATION AND 2 DRUG ELUTING STENTS WERE PLACED; ONE IN THE PROXIMAL CIRCUMFLEX ARTERY SEGMENT AND ANOTHER IN THE FIRST LEFT POSTEROLATERAL BRANCH SEGMENT. HEPARIN WAS GIVEN TO PREVENT DEEP VENOUS THROMBOSIS. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. IN THE INVESTIGATOR'S OPINION, THE EVENT OF CORONARY ARTERY DISEASE PROGRESSION WAS CONSIDERED SERIOUS DUE TO HOSPITALIZATION AND AS A MEDICALLY IMPORTANT EVENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R UNKNOWN PROMUS #3