BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2981580 · Received February 27, 2013

    Report

    Report Number
    2134265-2013-00977
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). 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)(4). IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, ANGINA AND VESSEL DISSECTION OCCURRED. IN (B)(6) 2013, THE SUBJECT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASSIFICATION IIIB) AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH REVEALED A 70% STENOSED DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE LESION WAS 14 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM AND WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.50 X 16 MM PROMUS ELEMENT PLUS STENT. THE STENT WAS POST-DILATED TO 20 ATMS WITH A 3.50 X 6 MM QUANTUM APEX BALLOON CATHETER. FOLLOWING PLACEMENT OF THE 3.50 X 16 MM PROMUS ELEMENT PLUS STENT, A GRADE C VESSEL DISSECTION WAS NOTED IN THE MID RCA. THE DISSECTION WAS TREATED BY PLACING A 3.0 X 12 MM PROMUS ELEMENT PLUS STENT DISTALLY, AND OVERLAPPING, WITH THE FIRST STENT. FOLLOWING THIS, RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED. TWO DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED DUE TO CARDIAC ANGINA AND WAS HOSPITALIZED. ANGIOGRAPHY REVEALED THE PREVIOUSLY IMPLANTED STENTS WERE PATENT. THE FOLLOWING DAY, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83471 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911416350 15023316

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R