BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2973028 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00922
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    September 14, 2012
    Report Date
    January 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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

    (B)(4). SAME CASE AS MDR#2134265-2013-00923. SAME PATIENT AS MDR#2134265-2013-01274 AND 2134265-2013-01275. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASS IIB), AND THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 90% STENOSED, 36 X 3 MM TARGET LESION WAS LOCATED IN THE PROXIMAL AND MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS TREATED WITH PRE-DILATATION, RESULTING IN A GRADE A DISSECTION WHICH DID NOT REQUIRE INTERVENTION. PLACEMENT OF A 3.00 X 38 MM STUDY STENT WAS ATTEMPTED, BUT THE DEVICE WAS UNABLE TO CROSS THE LESION. A SECOND, 2.50 X 28 MM STUDY STENT WAS IMPLANTED. A THIRD, 3.00 X 12 MM STUDY STENT WAS IMPLANTED DUE TO INADEQUATE LESION COVERAGE. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. ON THE SAME DAY, A NON Q-WAVE MYOCARDIAL INFARCTION (MI) OCCURRED. NO ACTION WAS TAKEN TO TREAT THE MI. TWO DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE ANGIOGRAPHY REVEALED VESSEL OCCLUSION WITHOUT SYMPTOMS OR OBJECTIVE SIGNS OF ISCHEMIA. DIAGNOSTIC ANGIOGRAPHY REVEALED PRE-TREATMENT TIMI FLOW 0. THE TOTALLY OCCLUDED TARGET VESSEL/TARGET LESION, LOCATED IN THE PROXIMAL LAD, WAS TREATED WITH PLACEMENT OF AN UNSPECIFIED DRUG-ELUTING STENT RESULTED IN TIMI FLOW 3. REMOTE TARGET VESSEL REVASCULARIZATION OF THE DISTAL LAD WAS PERFORMED AFTER THE OCCLUSION WAS RE-OPENED. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS ON THE SAME DAY. THE PATIENT WAS DISCHARGED FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77100 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R