BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 5608257 · Received April 26, 2016

    Report

    Report Number
    2134265-2016-03639
    Event Type
    Injury
    Date Received
    April 26, 2016
    Date of Event
    February 16, 2011
    Report Date
    March 31, 2016
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: 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)(6) CLINICAL TRIAL, IT WAS REPORTED THAT A DISSECTION OCCURRED. IN (B)(6) 2010, THE PATIENT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION - IIIA) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 3.5X35MM DE NOVO, SAPHENOUS VEIN GRAFT WAS LOCATED IN THE 1ST OBTUSE MARGINAL TARGET LESION WITH 80% STENOSIS. THE TARGET LESION WAS TREATED WITH PRE DILATION AND PLACEMENT OF TWO PROMUS ELEMENT STENTS, SIZES 3.50X24MM AND 3.50X16MM. RESIDUAL STENOSIS WAS 20% AND POST DILATION WAS NOT PERFORMED. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN, CLOPIDOGREL AND OTHER ANTICOAGULANTS. IN (B)(6) 2011, 65 DAYS POST INDEX PROCEDURE, THE PATIENT WAS BROUGHT BACK TO THE HOSPITAL FOR A PLANNED PERCUTANEOUS CORONARY INTERVENTION OF THE CIRCUMFLEX VESSEL DUE TO BYSTANDER DISEASE. STENOSIS OF THE LONG LESION FROM THE PROXIMAL LEFT CIRCUMFLEX (LCX) TO THE DISTAL LCX WAS TREATED WITH PRE DILATION. A 3.0X32MM PROMUS ELEMENT STENT ALONG WITH A 2.5X28MM PROMUS STENT WERE DEPLOYED IN THE LESION. POST DEPLOYMENT OF THE 3.0X32MM PROMUS ELEMENT STENT, A DISSECTION AT THE OUTFLOW OF THE STENT IN THE PROXIMAL LCX WAS NOTED. THE DISSECTION WAS TREATED WITH PLACEMENT OF ANOTHER 2.75X16MM PROMUS STENT TO COVER THE DISSECTION. THE EVENT WAS CONSIDERED RESOLVED ON THE SAME DAY WITHOUT RESIDUAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263655 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK634

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention