BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT

    MDR report key: 756903 · Received August 29, 2006

    Report

    Report Number
    6000093-2006-01639
    Event Type
    Death
    Date Received
    August 29, 2006
    Date of Event
    May 11, 2006
    Report Date
    August 1, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFORMATION BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY. SAME CASE AS 6000093-2006-01638, 01640. IT WAS REPORTED THAT 328 DAYS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT HAD A MYOCARDIAL INFARCTION (MI) AND A REINTERVENTION. THREE DAYS LATER AND 331 DAYS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 1 DE NOVO 10-20MM LONG TARGET LESION, WITH 85% STENOSIS, LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX. THE LESION WAS PREDILATED WITH AN ANGIOPLASTY BALLOON AT 9 ATMS. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 3X16MM TAXUS EXPRESS2 DRUG-ELUTING STENT (DES) AT 9 ATMS. POST IMPLANT WAS 0% AND TIMI FLOW WAS 3. THE PATIENT WAS DISCHARGED 4 DAYS POST-INDEX PROCEDURE ON PLAVIX. THE PATIENT PRESENTED 328 DAYS POST INDEX PROCEDURE WITH ACUTE MYOCARDIAL INFARCTION AND SHOCK. SHE WAS HYPOTENSIVE AND HAD INTERMITTENT BRADYCARDIA WHICH HAD PROGRESSED TO A THIRD DEGREE AV BLOCK AT PRESENTATION. SHE UNDERWENT SUCCESSFUL BALLOON ANGIOPLASTY AND IMPLANTATION OF A 3.0X28MM AND A 3.0X20MM TAXUS EXPRESS2 DES TO A 100% STENOSED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY. POST STENOSIS WAS 0%. A TRANSVENOUS TEMPORARY PACERWIRE WAS ALSO PLACED FOR THE COMPLETE HEART BLOCK. HER LEFT VENTRICULAR SYSTOLIC FUNCTION APPEARED INTACT BY LC ANGIOGRAPHY AND A BEDSIDE ECHO. HER RIGHT VENTRICLE WAS SEVERELY HYPOKINETIC. SHE WAS AGGRESSIVELY TREATED FOR RIGHT VENTRICULAR INFARCT WITH IV FLUID AND VASOPRESSORS (DOPAMINE, NOR EPINEPHRINE AND VASOPRESSIN). SHE REMAINED IN CRITICAL CONDITION AND DEVELOPED MULTI-ORGAN FAILURE. ONE DAY POST REINTERVENTION, SHE HAD "RUNS OF VENTRICULAR TACHYCARDIA". TWO DAYS POST REINTERVENTION, THE PATIENT HAD PERSISTENT HYPOTENSION REQUIRING ESCALATING DOSES OF VASOPRESSORS. THE PATIENT HAD BEEN MAINTAINED ON 100% OXYGEN, BUT HAD RUNS OF DESATURATIONS WHILE REQUIRING INTERMITTENT NITRIC OXIDE THERAPY TO HELP WITH HER PULMONARY PRESSURES. THREE DAYS AFTER THE INTERVENTION AND 331 DAYS POST-INDEX PROCEDURE, THE PATIENT HAD PROFOUND PERSISTENT HYPOTENSION AND IT WAS DECIDED NOT TO PURSUE FURTHER AGGRESSIVE THERAPY INCLUDING CPR. THE PATIENT'S VASOACTIVE MEDICATIONS WERE STOPPED AND SHE SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3X28MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death