BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3190975 · Received June 26, 2013

    Report

    Report Number
    2134265-2013-04592
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    January 7, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. 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)(6) CLINICAL STUDY. SAME CASE AS MDR ID: 2134265-2013-04454; 2134265-2013-03348; 2134265-2013-04455. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED. ON (B)(6) 2013, THE SUBJECT PRESENTED DUE TO ABNORMAL STRESS TEST, WAS DIAGNOSED WITH STABLE ANGINA AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED 3 TARGET LESIONS. THE FIRST WAS LOCATED IN THE DIST RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.25 X 12 MM PE PLUS STENTS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE SECOND WAS LOCATED IN THE PROXIMAL RCA WITH 60% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00 X 38 MM PE PLUS STENT .FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE THIRD TARGET LESION WAS LOCATED IN THE MID RCA WITH 60% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 2.25 X 20 MM, 2.50 X 24 MM, 2.50 X 12 MM PE PLUS STENTS IN OVERLAPPING FASHION. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. DURING THE PROCEDURE, FOLLOWING THE PLACEMENT OF THE 2.25 X 12 MM PE PLUS STENT IN THE DISTAL RCA, GRADE C DISSECTION OCCURRED WHICH WAS TREATED WITH PLACEMENT OF A 3.00 X 38 MM PE PLUS STENT IN THE PROXIMAL RCA AND 2.25 X 20 MM, 2.50 X 24 MM, AND 2.50 X 12 MM PE PLUS STENTS IN THE MID RCA. FINAL IVUS RESULTS REVEALED THAT NO DISSECTIONS VISUALIZED AND STENTS ARE WELL-APPOSED. THAT DAY, THE EVENT WAS CONSIDERED RESOLVED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291031 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412250 15532363

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention