BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3800276 · Received May 8, 2014

    Report

    Report Number
    2134265-2014-02550
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION # 1 WAS AN OSTIAL DE NOVO LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) WITH 80% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.8 MM. SUBSEQUENTLY, THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 12 MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2014, THE PATIENT PRESENTED DUE TO ANGINA AND WAS HOSPITALIZED. THE 75% STENOSED WAS LOCATED IN THE DISTAL LCX WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI), WITH 10% RESIDUAL STENOSIS. SUBSEQUENTLY, THE 95% IN-STENT RESTENOSIS (ISR) OF THE STUDY STENT DEPLOYED IN THE PROXIMAL LCX WAS TREATED WITH PERCUTANEOUS CORONARY INTERVENTION (PCI), WITH 10% RESIDUAL STENOSIS. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277127 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412250 15532363

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| R