BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT ¿

    MDR report key: 2780745 · Received October 10, 2012

    Report

    Report Number
    2134265-2012-06071
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    February 25, 2011
    Report Date
    September 13, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    SIMILAR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME PATIENT AS MDR ID#: 2134265-2012-06072. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD A MYOCARDIAL INFARCTION (MI). IN (B)(6) 2011, THE PATIENT PRESENTED DUE TO STABLE ANGINA (CCS CLASSIFICATION 2) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 1ST BIFURCATED OSTIAL TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (PROX LCX) WITH 99% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.22MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 4.00X32MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE 2ND DE NOVO OSTIAL TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH 70% STENOSIS AND WAS 10MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.97MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00X20MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS FOLLOWING POST-DILATION. ROTATIONAL ATHERECTOMY AND KISSING BALLOON TECHNIQUE WERE PERFORMED DURING THE PROCEDURE. ON THE NEXT DAY POST INDEX PROCEDURE, ELEVATED TROPONIN VALUES WERE OBSERVED AND ECG NOTED THE PATIENT EXPERIENCED A NON Q-WAVE MYOCARDIAL INFARCTION. THE PATIENT DID NOT EXPERIENCE ISCHEMIC SYMPTOMS. NO ACTION WAS TAKEN TO TREAT THIS EVENT. THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS ELEMENT ¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911332400 13595395

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other