BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING STENT

    MDR report key: 814448 · Received July 12, 2006

    Report

    Report Number
    6000089-2006-01421
    Event Type
    Death
    Date Received
    July 12, 2006
    Date of Event
    March 26, 2006
    Report Date
    June 15, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 INFO BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY #0652027-LB SAME CASE AS 6000089-2006-01422. IT WAS REPORTED THAT 10 DAYS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPIRED. THE INDEX PROCEDURE TREATED 1 DE NOVO Y-SHAPED BIFURCATED LESION. THE TARGET LESION WAS A 3.5MM VESSEL DIAMETER, 66MM LONG, WITH MILD CALCIFICATION AND MILD TORTUOSITY, 90% STENOSIS, IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY (PROXIMAL SITE) EXTENDING TO THE 1ST DIAGONAL BRANCH (DISTAL SITE). THE LESION WAS PREDILATED WITH A MONORAIL MAVERICK2 2X15MM BALLOON. THE PHYSICIAN IMPLANTED TWO OVER-LAPPING STENTS, A TAXUS EXPRESS2 2.75X16MM DRUG-ELUTING STENT (DES) AND A TAXUS EXPRESS2 3.5X20MM DES AT 14 ATMS. POST IMPLANT, THE LESION WAS 100% STENOSIS, TIMI FLOW 0. THE "PT DEVELOPED INSITU THROMBUS FOLLOWING INITIAL STENT DEPLOYMENT, SECONDARY TO UNDER ANTI-COAGULATION AND POSSIBLY EXACERBATED BY THE COMPLEXITY OF THE STENT DEPLOYMENT. PRIOR MEDICATIONS WERE IV HEPARIN. MEDICATIONS DURING PROCEDURE WERE -IV HEPARIN, DIAMORPHINE, MIDAZOLAM, AND ABCIXIMAB. PT REQUIRED TEMPORARY ANAESTHETIC SUPPORT DURING PROCEDURE, BUT WAS BREATHING SPONTANEOUSLY WITH NORMAL CONCIOUS LEVEL AND GOOD HAEMODYNAMIC OUTCOME. THIS IN-PT RECOVERY WAS COMPLICATED BY PULMONARY CONGESTION RELATED TO RESULTANT LEFT VENTRICULAR DYSFUNCTION ASCRIBED TO TRANSIENT ISCHAEMIC ATTACK, AT THE TIME OF HIS PROLONGED RESUSCITATION PROCEDURE. HOWEVER, OVER A ONE WEEK PERIOD HE MADE AN EXCELLENT RECOVERY" AND WAS DISCHARGED HOME 9 DAYS POST-INDEX PROCEDURE, ON ASPIRIN AND PLAVIX. INFORMATION RECEIVED INDICATED THAT THE DAY AFTER DISCHARGE, THE PT DEVELOPED FURTHER CHEST PAIN AND WAS ADMITTED TO HIS LOCAL HOSP. APPARENTLY, HE "SUFFERED RE-INFARCTION ASSUMED RELATED TO THE STENT THROMBOSIS, DESPITE APPROPRIATE TREATMENT WITH ASPIRIN AND CLOPIDOGREL." THE PT EXPIRED ONE DAY AFTER DISCHARGE, TEN DAYS POST-INDEX PROCEDURE. CAUSE OF DEATH WAS INDICATED AS "PRESUMED STENT THROMBOSIS." THE PHYSICIAN INDICATED THE DEATH WAS UNRELATED TO THE TAXUS STENT. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 2.75X16MM 7657769

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death