BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 3202743 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04633
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A 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 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT THE TIME OF THE EVENT, THE PATIENT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION. PEAK CARDIAC ENZYMES VALUES AND ABNORMAL ELECTROCARDIOGRAM (ECG) WERE NOTED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT POST CORONARY STENTING TREATMENT PROCEDURE, PATIENT EXPERIENCED ANGINA AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2012 THE SUBJECT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION #1 WAS LOCATED IN THE SVG TO DISTAL LAD WITH 70% STENOSIS AND WAS 20 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 MM X 28 MM PE PLUS STENT. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. THE SUBJECT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013 THE SUBJECT PRESENTED DUE TO UNSTABLE ANGINA AND WAS HOSPITALIZED ON THE SAME DAY. TWO DAYS AFTER, THE 95% RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT LOCATED IN THE SVG TO DISTAL LAD WAS TREATED WITH PCI WITH 0% RESIDUAL STENOSIS (TVR). THE FOLLOWING DAY, THE EVENT WAS CONSIDERED AS RESOLVED AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO MID LEFT ANTERIOR DESCENDING (LAD) AND NOT SVG TO DISTAL LAD AS PREVIOUSLY REPORTED. IN ADDITION, THE TARGET VESSEL REVASCULARIZATION WAS PERFORMED IN THE SVG TO FIRST DIAGONAL AND NOT SVG TO DISTAL LAD.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET VESSEL REVASCULARIZATION WAS PERFORMED IN THE SAPHENOUS VEIN GRAFT (SVG) TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY AND NOT SVG TO FIRST DIAGONAL. AND THE IN-STENT RESTENOSIS (ISR) WAS TREATED WITH PLACEMENT OF A 3.5 X18MM NON-BSC STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303002 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911428350 15190159

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R