BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3222579 · Received July 12, 2013

    Report

    Report Number
    2134265-2013-04840
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS AS IT WAS IMPLANTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. 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 2134265-2013-04839. (B)(4). IT WAS REPORTED THAT SUBSEQUENT TO A STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED ATYPICAL CHEST PAIN. THE PATIENT PRESENTED WITH STABLE ANGINA IN (B)(6) 2013 AND UNDERWENT A CARDIAC CATHETERIZATION PROCEDURE WHICH REVEALED 2 TARGET LESIONS. THE FIRST WAS A 80% STENOSED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.0MM AND A LESION LENGTH OF 16MM. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON AND 2.50X38MM STUDY STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. THE SECOND WAS A 90% STENOSED LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM AND A LESION LENGTH OF 28MM. THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON AND 3.0X20MM STUDY STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON DUAL ANTIPLATELET. IN (B)(6) 2013 THE PATIENT RETURNED WITH ATYPICAL CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324020 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420300 15511519

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other