BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3202912 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04679
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

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

    Description of Event or Problem · 1

    (B)(4) . IT WAS REPORTED THAT POST PERCUTANEOUS CORONARY INTERVENTION, SLOW FLOW OCCURRED. IN (B)(6) 2010, THE PATIENT HAVE SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE DISTAL OF THE LEFT CIRCUMFLEX ARTERY WITH 99% STENOSIS, A LENGTH OF 20 MM AND REFERENCE VESSEL DIAMETER OF 3.00 MM. THE LESION WAS PRE-DILATED USING AN UNSPECIFIED BALLOON CATHETER AND PLACEMENT OF A 3.00 X 20 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE PROCEDURE WAS DONE TO TREAT THE TARGET LESION AT DISTAL OF THE LEFT CIRCUMFLEX ARTERY WITH 99% PRE PROCEDURE STENOSIS AND THE TIMI FLOW WAS 3. THE LESION WAS PRE-DILATED USING AN UNSPECIFIED BALLOON CATHETER AND PLACEMENT OF 3.00 X 20 MM STUDY STENT AND AFTER POST DILATATION THE RESIDUAL STENOSIS WAS 0% AND TIMI FLOW WAS 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302752 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320300 15848119

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention