BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2810111 · Received October 31, 2012

    Report

    Report Number
    2134265-2012-06625
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    July 4, 2012
    Report Date
    October 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).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

    IT WAS INITIALLY REPORTED THAT THE PATIENT PRESENTED IN (B)(6) 2012 WITH CORONARY HEART DISEASE AND THE CORRECTED INFORMATION IS THAT THE PATIENT PRESENTED WITH UNSTABLE ANGINA.

    Description of Event or Problem · 1

    (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, CORONARY HEART DISEASE OCCURRED AND TARGET LESION REVASCULARIZATION WAS PERFORMED. IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 15MM X 3.5MM, 90% STENOSED TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 20 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED THREE DAYS LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2012, THE PATIENT PRESENTED WITH CORONARY HEART DISEASE AND WAS HOSPITALIZED. THE PATIENT UNDERWENT TARGET LESION REVASCULARIZATION. THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED FIVE DAYS LATER.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT WHEN THE PATIENT WAS HOSPITALIZED IN (B)(6) 2012, DIAGNOSTIC ANGIOGRAPHY REVEALED 80% PRE-TREATMENT DIAMETER STENOSIS AND TIMI FLOW 3. THE TARGET VESSEL/TARGET LESION, LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY, WAS TREATED WITH PLACEMENT OF A DRUG ELUTING STENT. RESIDUAL DIAMETER STENOSIS WAS 0% AND TIMI FLOW 3. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911320350 13580876

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R