BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2962411 · Received February 14, 2013

    Report

    Report Number
    2134265-2013-00710
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    August 6, 2012
    Report Date
    January 18, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    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 COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. 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

    (B)(6). SAME CASE AS MDR# 2134265-2013-00709, 2134265-2013-00711, AND 2134265-2013-00732. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A VESSEL SPASM OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA (BRAUNWALD CLASS IIB) AS WELL AS SILENT ISCHEMIA, AND WAS REFERRED FOR CARDIAC CATHETERIZATION. A 0.014 PT2 185 CM GUIDE WIRE WAS INTRODUCED. THE FIRST 80% STENOSED, 12 X 3.0 MM, TARGET LESION WAS A DE NOVO, BIFURCATED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING TO THE PROXIMAL LAD. THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATATION. DURING THE BALLOON ANGIOPLASTY, A GUIDE WIRE TRAUMA WAS NOTED IN THE LAD WITH ACUTE CLOSURE (NO FLOW) ALONG WITH A GRADE F DISSECTION WHICH RESULTED IN CHEST PAIN AND TRANSIENT HYPOTENSION. THE ISSUES WERE RESOLVED WITH A 2.5 MM BALLOON INFLATION AND PLACEMENT OF TWO PROMUS ELEMENT PLUS STENTS, 2.50 X 16 MM AND 3.0 X 20 MM, WITH 0% RESIDUAL STENOSIS. AFTER THE STENTS WERE DEPLOYED, THERE WAS A SPASM NOTED JUST DISTAL TO THE MID VESSEL STENT IN THE LAD WHICH WAS CROSSED AGAIN WITH THE 2.5 MM BALLOON WITH EXCELLENT RESULTS. THE SECOND, 90% STENOSED, 8 X 2.5 MM TARGET LESION WAS A DE NOVO, BIFURCATED LESION LOCATED IN THE RAMUS. THE SECOND TARGET LESION WAS TREATED WITH THE PLACEMENT OF A 2.50 X 12 MM PROMUS ELEMENT PLUS STENT WITH 0% STENOSIS. DURING THIS PROCEDURE A STENT STRUT OBSTRUCTION WAS NOTED IN THE CIRCUMFLEX PROPER, THE SIDE BRANCH WAS COVERED BY THE STENT INTO THE INTERMEDIATE BRANCH. THE OBSTRUCTION WAS CROSSED AND BALLOONED WITH 2.5 X 8 MM BALLOON WITH EXCELLENT RESULTS. THE PATIENT RECOVERED THE SAME DAY AND THE EVENT WAS CONSIDERED RESOLVED. TWO DAYS LATER, THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65527 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911420300 15227082

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention GUIDE WIRE: PT2 185CM 0.014