BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3094641 · Received May 6, 2013

    Report

    Report Number
    2024168-2013-02805
    Event Type
    Death
    Date Received
    May 6, 2013
    Date of Event
    March 1, 2004
    Report Date
    April 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE UNKNOWN RX XIENCE V STENTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT. THE ADDITIONAL ADVERSE PATIENT EFFECTS REFERENCED ARE BEING FILED UNDER A SEPARATE MEDWATCH REPORT. DATE OF EVENT ESTIMATED AS (B)(6) 2004, THE EARLIEST POSSIBLE DATE AS THE ARTICLE INDICATES FROM (B)(6) 2004 TO (B)(6) 2010. OUT-OF-HOSPITAL: 7 (10.4%) TARGET LESION REVASCULARIZATION; 7 (10.4%) ISCHEMIA; 7 (10.4%) TARGET VESSEL REVASCULARIZATION. DATE OF IMPLANT ESTIMATED AS (B)(6) 2004, THE EARLIEST POSSIBLE DATE AS THE ARTICLE INDICATES FROM (B)(6) 2004 TO (B)(6) 2010. ATTACHMENT: ARTICLE: (JOURNAL OF THE CHINESE MEDICAL ASSOCIATION, 2013, 76:71-77): THE USE AND CLINICAL OUTCOMES OF ROTABLATION IN CHALLENGING CASES IN THE DRUG-ELUTING STENT ERA. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE AS A KNOWN ADVERSE EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE, THE USE AND CLINICAL OUTCOMES OF ROTABLATION IN CHALLENGING CASES IN THE DRUG-ELUTING STENT ERA. IT WAS NOTED IN THE ARTICLE THAT FROM (B)(6)2004 TO (B)(6) 2010, ALL CONSECUTIVE PATIENTS WHO REQUIRED ROTATION ATHERECTOMY (RA) TREATMENT FOR SEVERELY CALCIFIED DE NOVO LESIONS OF NATIVE CORONARY ARTERIES FOLLOWED BY DRUG-ELUTING STENT IMPLANTATION WERE QUERIED FROM THE CATH LAB DATABASE AND RECRUITED. A TOTAL OF 67 CONSECUTIVE PATIENTS WITH 71 VERY COMPLEX, HEAVILY CALCIFIED CORONARY LESIONS TREATED WITH ROTATIONAL ATHERECTOMY (RA) PLUS DRUG-ELUTING STENTS. IT WAS NOTED IN THE ARTICLE THAT PROMUS STENTS WERE IMPLANTED IN NINE LESIONS, XIENCE V STENTS WERE IMPLANTED IN FOUR LESIONS, MULTIPLE STENTING WAS USED IN 41 LESIONS AND AMONG 28 BIFURCATION LESIONS A TWO-STENT STRATEGY WAS USED IN 10 LESIONS. CLINICAL OUTCOMES WERE AS FOLLOWS: IN-HOSPITAL: 5 (7.5%) MAJOR ADVERSE CARDIAC EVENT (MACE); 5 (7.5%) DEATH; 1 (1.5%) NON-Q WAVE MYOCARDIAL INFARCTION (MI); 3 (4.5%) DISSECTION TYPE B ON NHLBI; 2 (3.0%) DISSECTION TYPE C ON NHLBI. OUT-OF-HOSPITAL: 12 (17.9%) MACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196481 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death