BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 4151716 · Received October 8, 2014

    Report

    Report Number
    2134265-2014-06159
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 19, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID# 2134265-2014-05943. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT ANGINA AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY,CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS AN OSTIAL LESION LOCATED IN RAMUS WITH 90% ISR OF UNSPECIFIED BARE METAL STENT AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.75MM X 20MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, THE PATIENT PRESENTED WITH CHEST PAIN AND A 3.0 X 16 MM PROMUS ELEMENT¿ PLUS STENT WAS IMPLANTED IN RAMUS. IN (B)(6) 2014, THE PATIENT PRESENTED A HISTORY OF RECURRENT ANGINAL SYMPTOMS SUCH AS CHEST PAIN, SHORTNESS OF BREATH AND PATIENT WAS HOSPITALIZED ON THE SAME DAY. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED 80%-90% PROXIMAL ISR OF PREVIOUSLY PLACED 2.75MM X 20MM AND 3.0 X 16 MM PROMUS ELEMENT¿ PLUS STENTS IN RAMUS. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.5MM X 15 MM NON-BSC DRUG-ELUTING STENT. POST DEPLOYMENT, AN UNSPECIFIED BALLOON WAS PULLED BACK IN THE LEFT MAIN AND INFLATION WAS PERFORMED TO FLUTE THE PROXIMAL EDGES OF THE STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE EVENT WAS CONSIDERED AS RESOLVED AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIGOREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633243 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R