BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 5054346 · Received September 3, 2015

    Report

    Report Number
    2134265-2015-05912
    Event Type
    Injury
    Date Received
    September 3, 2015
    Date of Event
    April 16, 2015
    Report Date
    August 10, 2015
    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)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED 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 2134265-2015-05911. (B)(6). IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 85% STENOSIS, AND WAS 40MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, AND PLACEMENT OF 3.00X 20MM PROMUS ELEMENT, 2.2.75X28MM PROMUS ELEMENT STENTS. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. THREE DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2015, THE PATIENT EXPERIENCED UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. THE FOLLOWING DAY, DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED AND REVEALED 75% STENOSIS IN THE TARGET LESION PROXIMAL LAD AND THE PATIENT SUBSEQUENTLY UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) TO TREAT THE ISR. THE RESIDUAL STENOSIS POST TOTAL VESSEL REVASCULARIZATION (TVR) WAS 0%. TWO DAYS AFTER, THE EVENT WAS CONSIDERED AS RECOVERED/RESOLVED AND THE PATIENT WAS DISCHARGED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583740 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911328270 0015909367

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R