BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3003823 · Received March 14, 2013

    Report

    Report Number
    2134265-2013-01453
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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# 2134265-2013-01454 AND 01455. (B)(4) CLINICAL STUDY IT WAS REPORTED POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED AN ALLERGIC REACTION. (B)(6) 2012 THE 99% STENOSED AND 10MM LONG DE-NOVO TARGET LESION WAS LOCATED IN MID LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A TWO 3.0X12MM AND A 3.50X12MM PROMUS ELEMENT PLUS STENT, RESULTING IN 0% RESIDUAL STENOSIS FOLLOWING POST DILATION. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON CLOPIDOGREL AND ASPIRIN. IN (B)(6) 2013, THAT PATIENT EXPERIENCED AN ALLERGIC REACTION AND WAS HOSPITALIZED. THE PATIENT WAS TREATED WITH MEDICATIONS AND THE EVENT WAS CONSIDERED RECOVERING/RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106758 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911412300 15602431

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention