BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3232885 · Received July 18, 2013

    Report

    Report Number
    2134265-2013-04858
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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 INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR ID#: 2134265-2013-05344. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, MYOCARDIAL INFARCTION (MI) AND VESSEL JAILING OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH 75% STENOSIS AND WAS 5MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.75X16MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. DURING THE PROCEDURE, THE 1ST DIAGONAL BRANCH (DX1) WAS ATTEMPTED TO BE INTERVENED WITH WIRE. HOWEVER, BOTH A CHOICE PT GUIDE WIRE AND A LUGE GUIDEWIRE WERE UNABLE TO CROSS THE LESION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO CHEST PAIN TO AN OUTSIDE ER FACILITY AND WAS DIAGNOSED WITH MI. SUBSEQUENTLY THE PATIENT WAS TRANSFERRED TO THE ENROLLING SITE FOR EVALUATION AND POSSIBLE INTERVENTION. ELEVATED CARDIAC ENZYME VALUES WERE OBSERVED AND CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED JAILING OF THE DX1 BY THE STUDY STENT WHICH RESULTED IN INCREASED NARROWING FROM 70% TO 90% STENOSIS AT THE OSTIUM OF DX1. 70% STENOSIS WAS NOTED IN THE MID LEFT CIRCUMFLEX ARTERY (MID LCX), WHICH WAS TREATED WITH PLACEMENT OF A 2.75X12MM PROMUS ELEMENT PLUS STENT. POST STENT PLACEMENT MILD DISSECTION WAS NOTED, WHICH WAS SUBSEQUENTLY TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.5X16MM PROMUS STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED AND THE EVENT WAS CONSIDERED AS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335135 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416270 15744724

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R