BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ?

    MDR report key: 3222485 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04732
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    September 29, 2012
    Report Date
    June 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 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 FOLLOWING A CORONARY STENTING PROCEDURE, STENT THROMBOSIS OCCURRED. IN (B)(6) 2012 THE CONCENTRIC, 100% STENOSED CHRONIC TOTAL OCCLUSION, DE NOVO TARGET LESION WAS LOCATED IN THE BIFURCATION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. THE LESION WAS NOTED TO HAVE A SIGNIFICANT BEND OF <=45 DEGREE, TIMI FLOW 0, WITH THROMBOSIS AND NO ANEURYSM. PRE-DILATATION WAS PERFORMED, NO DISSECTION OCCURRED. A 3.0 X 28 MM PROMUS ELEMENT STENT WAS IMPLANTED AT 6 ATMS. AFTER POST-DILATATION WAS PERFORMED, THE IMAGE SHOWED THROMBOSIS. THE THROMBOSIS WAS ASPIRATED AND A NON BSC STENT WAS IMPLANTED AT THE LESION; HOWEVER, IT WAS NOT IMPROVED. DILATATION WAS PERFORMED WITH AN UNSPECIFIED DEVICE WHICH RESULTED IN IMPROVEMENT. THE PROCEDURE WAS COMPLETED. APPROXIMATELY ONE OR TWO WEEKS AFTER, FOLLOW UP ANGIOGRAPHY REVEALED THE LESION AT PROXIMAL LAD. A NON BSC STENT WAS IMPLANTED AND PCI WAS DONE. THE PATIENT'S STATUS WAS STABLE. IN (B)(6) 2012 THE PATIENT WAS DISCHARGED. IN (B)(6) 2013, 6 MONTH FOLLOW UP WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323560 PROMUS ELEMENT ? STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328300

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other