BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3090330 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-02834
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(6). DEVICE EVALUATION 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

    SAME PATIENT AS MDR ID# 2134265-2013-02833 AND 2134265-2013-03225. (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPERIENCED CHEST PAIN. (B)(6) 2010 - THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 80% STENOSED AND 30MM LONG TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING A 2.5 X 20 MM APEX BALLOON. CORE LAB REPORTS NOTED AN "EXTRALUMINAL 'C' DISSECTION WITH STAINING AFTER BALLOON PRE-DILATION WHICH WAS TREATED WITH PLACEMENT OF A 3.0 X 38 MM PROMUS ELEMENT STUDY STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT EXPERIENCED CHEST PAIN WITH EXERTION DURING BALLOON ANGIOPLASTY AND STENTING, THE CHEST PAIN WAS RESOLVED AFTER TREATMENT WITH INTRACORONARY NITROGLYCERINE AND DEFLATION. JAILING AT THE 2ND DIAGONAL WITH 70% OSTIAL STENOSIS WAS ALSO NOTED. NO FURTHER INTERVENTION WAS REQUIRED TO TREAT THE JAILING. IN ADDITION A NON-TARGET LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WAS TREATED WITH PLACEMENT OF A 2.5 X 18 MM NON STUDY DRUG ELUTING STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR CARDIAC CHEST PAIN. CORONARY ANGIOGRAPHY REVEALED 90% PROXIMAL 2ND DIAGONAL STENOSIS AT THE PROXIMAL EDGE OF THE STENTED SEGMENT OF THE LEFT ANTERIOR DESCENDING ARTERY. THREE DAYS POST HOSPITALIZATION THE 90% STENOSIS NOTED IN 2ND DIAGONAL WAS TREATED WITH LEFT INTERNAL MAMMARY ARTERY GRAFT TO LEFT ANTERIOR DESCENDING ARTERY, SAPHENOUS VEIN GRAFT TO 2ND DIAGONAL AND SAPHENOUS VEIN GRAFT TO DISTAL LEFT CIRCUMFLEX ARTERY. THREE DAYS LATER THE EVENT RESOLVED WITH RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191581 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911538300 12534251

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention