BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM

    MDR report key: 3103061 · Received May 9, 2013

    Report

    Report Number
    2134265-2013-03039
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    February 19, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE IS A COMBINATION PRODUCT.DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. 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 MFR ID # 2134265-2013-03040. (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPERIENCED ANGINA AND IN-STENT RESTENOSIS. THE 2.7X30MM 90% STENOSED TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED AND A 2.5X38MM PROMUS ELEMENT STENT WAS PLACED WITH 0% RESIDUAL STENOSIS. A SECOND NON-TARGET LESION IN THE OBTUSE MARGINAL (OM) ARTERY WAS PRE DILATED AND AN UNKNOWN 2.5X23MM DES STENT WAS IMPLANTED. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, PATIENT EXPERIENCED STABLE ANGINA AND WAS HOSPITALIZED, CORONARY ANGIOGRAPHY REVEALED 80% RESTENOSIS OF THE 2.75X24MM TAXUS LIBERTE STENT IMPLANTED IN THE PROXIMAL LAD. RESTENOSIS WAS TREATED WITH PLACEMENT OF A 3.0X22MM NON-BSC STENT, RESULTING IN 0% RESIDUAL STENOSIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202859 PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911538250 12540773

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention