BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 2935993 · Received January 30, 2013

    Report

    Report Number
    2134265-2013-00263
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 27, 2012
    Report Date
    January 3, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 CASE AS MDR ID#: 2134265-2013-00264, 2134265-2013-00265. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD CHEST PAIN AND MYOCARDIAL INFARCTION (MI). IN (B)(6) 2012, THE PATIENT PRESENTED WITH STABLE ANGINA (CCS CLASSIFICATION 2) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE DE NOVO 1ST TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (DIST RCA) WITH 90% STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.50X12MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS. THE DE NOVO 2ND TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (MID RCA) WITH 80% STENOSIS AND WAS 20MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 2.50X32MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS. THE DE NOVO 3RD TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PROX LAD) WITH 70% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.50X32MM PROMUS ELEMENT PLUS STENT, WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. FOLLOWING THE INDEX PROCEDURE, THE PATIENT HAD CHEST PAIN AND WAS TREATED WITH INTEGRELIN (EPTIFIBATIDE). TWO DAYS POST INDEX PROCEDURE, THE PATIENT WAS RE-ADMITTED DUE TO NON ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ELEVATED CARDIAC ENZYME VALUES WERE OBSERVED. MEDICATION WAS GIVEN TO TREAT THE MI. THE PATIENT WAS CONSIDERED RECOVERED AND WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41151 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911432250 15101292

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention