BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 3023647 · Received March 27, 2013

    Report

    Report Number
    2134265-2013-01753
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    February 27, 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

    EVENT DATE: 2012. (B)(6). 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#: 2134265-2013-01751, 2134265-2013-01752. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD HEART FAILURE. IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASSIFICATION: 2) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE DE NOVO TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 100% STENOSIS AND WAS 70MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF THREE OVERLAPPING PROMUS ELEMENT STENTS OF SIZE 2.75X32MM, 3.00X28MM AND 3.50X16MM, WITH 100% RESIDUAL STENOSIS. STENT THROMBOSIS WAS NOTED IN THE MID LAD, WHICH WAS TREATED WITH MEDICATION ONLY. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON AN UNKNOWN DATE IN 2012, THE PATIENT PRESENTED WITH HEART FAILURE AND WAS SUBSEQUENTLY HOSPITALIZED. MEDICATION WAS GIVEN TO TREAT THIS EVENT. THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126007 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R