BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3032190 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-01916
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    November 23, 2012
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: 1945. DEVICE IS A COMBINATION PRODUCT. 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 STUDY. SAME CASE AS MFR ID # 2134265-2013-01946, 2134265-2013-01947. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPERIENCED ISCHEMIA AND IN-STENT THROMBOSIS. THE 3.6MM DIAMETER, 65% TO 75% STENOSED TARGET LESION WAS LOCATED IN A SAPHENOUS VEIN GRAFT (SVG) TO 1ST OBTUSE MARGINAL (OM1). THE 3.5X16MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE PROXIMAL SVG LESION, RESULTING IN 5% STENOSIS. THE SECOND 3.5X16MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE MID SVG LESION, RESULTING IN 5% STENOSIS. THE 3.5X20MM PROMUS ELEMENT STENT WAS IMPLANTED IN THE DISTAL SVG LESION, RESULTING IN 5% STENOSIS. IN (B)(6) 2012, PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH EXERCISE INDUCED ISCHEMIA. PATIENT UNDERWENT ANGIOGRAPHY WITHOUT REVASCULARIZATION. ANGIOGRAPHY REVEALED IN-STENT THROMBOSIS OF THE PREVIOUSLY IMPLANTED STENTS IN THE SVG TO OM1. MEDICATION WAS GIVEN TO TREAT THE THROMBOSIS EVENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136042 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911316350 13934933

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention