BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

    MDR report key: 2943919 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00252
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. 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

    (B)(4) CLINICAL STUDY. SAME CASE AS MDR2134265-2013-00251. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED RESTENOSIS AND PLAQUE SHIFT. IN (B)(6) 2010, THE PATIENT PRESENTED WITH CHEST PAIN AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 70% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 38 MM TAXUS LIBERTE STENT. FOLLOWING POST DILATATION, IVUS WAS PERFORMED. IVUS REVEALED GOOD STENT EXPANSION AND APPOSITION WITH PLAQUE SHIFT INTO THE DIAGONAL WHICH WAS TREATED WITH LOW PRESSURE DILATATION OF THE OSTIUM OF THE DIAGONAL RESULTING IN LESS THAN 10% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2013, THE PATIENT WAS SEEN FOR "PERSISTENT STABLE ANGINA" AND THE SUBJECT WAS HOSPITALIZED ON SAME DAY. LEXISCAN STRESS TEST REVEALED ISCHEMIA IN ANTERIOR WALL. CARDIAC CATHETERIZATION WAS RECOMMENDED WHICH REVEALED 90% FOCAL IN-STENT RESTENOSIS IN THE LAD. THIS WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 16 MM PROMUS ELEMENT STENT JUST BEYOND THE TAKE-OFF OF DIAGONAL. FOLLOWING POST DILATATION, PLAQUE SHIFT INTO THE 1ST DIAGONAL WAS NOTED WHICH WAS TREATED WITH DILATATION RESULTING IN 73% OSTIAL STENOSIS. THE 1ST DIAGONAL WAS TREATED WITH PLACEMENT OF A 2.25 X 12 MM PROMUS ELEMENT STENT WHICH WAS SLIGHTLY PROTRUDING INTO LAD. KISSING INFLATION BETWEEN THE LAD AND THE DIAGONAL WERE PERFORMED AT HIGH PRESSURES FOLLOWING STENT DEPLOYMENT IN BOTH VESSELS. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS LESS THAN 10%. THE EVENT WAS CONSIDERED TO BE RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47939 PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY UNK717

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR