BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS PREMIER?

    MDR report key: 4129879 · Received September 30, 2014

    Report

    Report Number
    2134265-2014-06166
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    July 19, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID: 2134265-2014-06083. (B)(6) CLINICAL TRIAL. IT WAS REPORTED THAT MYOCARDIAL INFARCTION (MI) AND STENT RESTENOSIS OCCURRED. THE PATIENT HAD TWO CONTIGUOUS PROMUS PREMIER¿ STENTS PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD)2 AND LAD3 IN (B)(6) 2013. IN (B)(6) 2014, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF CHEST PAIN AT REST ASSOCIATED WITH A VAGAL ACCOMPANIMENT, WHICH STOPPED WITH NITROGLYCERIN. AT THE EMERGENCY DEPARTMENT, THE PATIENT WAS GIVEN A LOADING DOSE OF ASPEGIC AND HEPARIN AND ADMITTED INTO THE CARDIOLOGY SERVICES DEPARTMENT. A CORONARY ANGIOGRAM REVEALED LONG SUB-OCCLUSIVE NARROW RESTENOSIS IN THE LAD2 AND LAD3 STENT AND THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI) 2 FLOW DELAY IN THE LAD IN THE PREVIOUSLY PLACED NON-STUDY, 3.5 X 20 MM PROMUS PREMIER¿ STENT. THE PATIENT WAS MOVED TO THE CARDIOVASCULAR SURGICAL DEPARTMENT FOR PLANNED EMERGENCY SURGICAL MYOCARDIAL REVASCULARIZATION IN VIEW OF HIS UNSTABLE CONDITION DESPITE NITRITE DERIVATIVES AND HEPARIN. THE SUBJECT UNDERWENT CORONARY ARTERY BYPASS GRAFTING (CABG) X 1 VESSEL WITH LEFT INTERNAL MAMMARY ARTERY (LIMA) TO MID LAD. THE POST-OPERATIVE TROPONIN PEAK WAS 186 NG/ML AND ECHOCARDIOGRAM REVEALED SEPTAL HYPO-KINESIS, MILDLY HYPO-KINETIC RV, DRY PERICARDIUM AND MINIMAL PLEURAL EFFUSION. IN A(B)(6) 2014, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608955 PROMUS PREMIER? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK758

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention