BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS¿ ELEMENT¿

    MDR report key: 2821481 · Received November 6, 2012

    Report

    Report Number
    2134265-2012-06612
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    April 4, 2011
    Report Date
    October 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION DEVICE. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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# 2134265-2012-06614 AND MDR ID#2134265-2012-06615. (B)(4). IT WAS REPORTED THAT POST A PCI (PERCUTANEOUS CORONARY INTERVENTION) THE PATIENT EXPERIENCE MYOCARDIAL INFARCTION (MI). THE PATIENT PRESENTED DUE TO MYOCARDIAL INFARCTION (STEMI) AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE FIRST LESION WAS LOCATED IN THE PROXIMAL RCA (RIGHT CORONARY ARTERY) EXTENDING TOWARDS DISTAL RCA. IT WAS 70 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM AND WITH 99% STENOSIS. AFTER THROMBOASPIRATION AND PREDILATATION TWO 3.00X28 MM TAXUS ELEMENT STENTS WAS IMPLANTED IN AN OVERLAPPING FASHION. FOLLOWING POST DILATATION RESIDUAL STENOSIS WAS 0%. ADDITIONALLY THIS LESION WAS TREATED WITH THE PLACEMENT OF 3.5X28MM NON BSC STENT IN THE MEDIAL-PROXIMAL SECTION OVERLAPPING THE STUDY STENT. A STAGED PROCEDURE WAS PLANNED FOR TREATMENT OF LESIONS IN THE OM1 (OBTUSE MARGINAL) AND D2 (DIAGONAL). THE STAGED PROCEDURE WAS PERFORMED 3 DAYS LATER. THE LESION LOCATED IN THE 1ST OM WAS DESCRIBED AS BIFURCATED, 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM AND WITH 95% STENOSIS. AFTER PREDILATATION A 3.00X16MM TAXUS ELEMENT WAS IMPLANTED WITH 0% RESIDUAL STENOSIS. THE LESION IN PROXIMAL LCX (LEFT CIRCUMFLEX ARTERY ) WAS TREATED WITH THE PLACEMENT OF A 3.0X12MM NON BSC STENT WITH GOOD ANGIOGRAPHIC RESULT. ON THE SAME DAY, ECG SUGGESTED A NON Q-WAVE MI. THE FOLLOWING DAY, PRIOR TO DISCHARGE, IT WAS NOTED THAT THE SUBJECT HAD ELEVATED TROPONIN VALUES AND AN MI WAS REPORTED. NO ISCHEMIC SYMPTOMS WERE OBSERVED AND NO OTHER ACTION WAS TAKEN. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS¿ ELEMENT¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902528300 13555743

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention