BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS? ELEMENT?

    MDR report key: 3355182 · Received September 18, 2013

    Report

    Report Number
    2134265-2013-06325
    Event Type
    Death
    Date Received
    September 18, 2013
    Date of Event
    September 30, 2012
    Report Date
    August 20, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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# 2134265-2013-06326; SAME CASE AS MDR ID# 2134265-2013-06328; SAME CASE AS MDR ID# 2134265-2013-06329; SAME CASE AS MDR ID# 2134265-2013-06373. (B)(4). IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION AND EXPIRED. (B)(6) 2011 THE PATIENT PRESENTED DUE TO STABLE ANGINA. THE PHYSICIAN TREATED THREE DIFFERENT LESIONS. LESION 1 WAS A LONG LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY TO DISTAL LAD WITH 75% STENOSIS AND WAS 65 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTATION OF OVERLAPPING 2.5 X 24 MM, 2.5 X 32 MM , AND 3.0 X 16 MM TAXUS ELEMENT STENTS. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. LESION 2 WAS LOCATED IN THE 1ST DIAGONAL WITH 75% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.4 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT USING A 2.5 X 16 MM TAXUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. LESION 3 WAS LOCATED IN THE 2ND OBTUSE MARGINAL WITH 75% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.8 MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT STENT PLACEMENT OF A 3.0 X 20 MM TAXUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. POST INDEX PROCEDURE, THE PATIENT HAD ELEVATED TROPONIN VALUES (PEAK TROPONIN= 137 NG/L, UL= 14 NG/L). NO ISCHEMIC SYMPTOMS WERE OBSERVED AND NO ACTION WAS TAKEN TO TREAT THIS EVENT. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND CLOPIDOGREL. (B)(6) 2013, 438 DAYS POST INDEX PROCEDURE THE PATIENT EXPERIENCED AN MYOCARDIAL INFARCTION AND SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469982 TAXUS? ELEMENT? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493902524250 13603203

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death