BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3162989 · Received June 11, 2013

    Report

    Report Number
    2134265-2013-03939
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 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 A CORONARY STENTING PROCEDURE, THE PATIENT HAD CHEST PAIN AND TARGET VESSEL REVASCULARIZATION OCCURRED. THE 90% STENOSED, DE NOVO AND 16MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 LESION WAS LOCATED IN THE MID SEGMENT OF RIGHT CORONARY ARTERY (RCA). IN (B)(6) 2012, THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT OF A 3.00 MM X 16 MM PE PLUS STENT WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE FOLLOWING DAY. ON (B)(6) 2013, THE SUBJECT RETURNED WITH CARDIAC CHEST PAIN, WAS HOSPITALIZED ON THE SAME DAY AND RECOMMENDED FOR CATHETERIZATION. THE 90% IN-STENT RESTENOSIS OF THE STUDY STENT LOCATED IN THE MID RCA WAS TREATED WITH BALLOON ANGIOPLASTY WITH 20% RESIDUAL STENOSIS AND A LESION LOCATED IN THE MID LAD WAS TREATED WITH A BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE FOLLOWING DAY, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262196 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416300 15134025

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R