BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 633806 · Received September 7, 2005

    Report

    Report Number
    6000089-2005-01336
    Event Type
    Injury
    Date Received
    September 7, 2005
    Date of Event
    February 17, 2005
    Report Date
    August 9, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT TARGET LESION 1 HAD RESIDUAL STENOSIS OF 0% AFTER IMPLANTATION. TARGET LESION 2 HAD A RESIDUAL STENOSIS OF 0% AFTER IMPLANTAION. TWO-THIRDS OF THE STENT, FROM TARGET LESION2, COVERED THE 2ND DIAGONAL WITH ONE THIRD EXTENDING INTO THE LAD PROPER. PLAN WAS MADE TO FURTHER EVALUATE THE RCA WITH AN OUTPATIENT MYOCARDIAL PERFUSION SCAN. LEFT CORONARY ANGIOGRAPHY 20 DAYS POST INDEX PROCEDURE REVEALED THAT THE LMCA HAD 10% DISTAL STENOSIS. THE LAD HAD 80% PROXIMAL STENOSIS, OCCLUSION OF THE MID LAD, DISTAL VESSEL FILLED BY LIMA GRAFT, AND OSTIAL THROMBUS OCCLUSION OF DIAG2 WITH COLLATERAL FILLING FROM THE DISTAL LAD. THE LCX HAD 20% OSTIAL STENOSIS OF OM1 AND OM2. THE OSTIUM OF THE 2ND DIAGONAL WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.5X16MM TAXUS STENT. THE PROXIMAL LAD WAS ALSO TREATED WITH PRIMARY STENTING USING A 3.5X16MM TAXUS STENT.

    Description of Event or Problem · 1

    SAME CASE AS MDR 6000089-2005-1337. SAME PATIENT AS MDR 6000089-2005-1334, AND 1335. IT WAS REPORTED THAT 20 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT UNDERWENT A TARGET VESSEL REINTERVENTION (TVR) OF THE 2ND DIAGONAL ARTERY. THE INDEX PROCEDURE TREATED TWO TARGET LESIONS. TARGET LESION 1 WAS A 2.5 MM VESSEL DIAMETER, 90% STENOSED REGION OF THE DISTAL CIRCUMFLEX ARTERY (CX). THE LESION WAS 15.0 MM IN LENGTH, WAS MILDLY TORTUOUS, AND HAD MILD CALCIFICATION. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING ONE TAXUS EXPRESS2 8.8% 2.5X20MM DRUG ELUTING STENT WITHOUT COMPLICATION. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. TARGET LESION 2 WAS A 2.75 MM VESSEL DIAMETER, 90% STENOSED, OSTIAL, BIFURCATED REGION OF THE 2ND DIAGONAL ARTERY. THE LESION WAS 10.0 MM IN LENGTH, WAS MILDLY TORTUOUS, AND HAD MILD CALCIFICATION. THE DR PREDILATED THE LESION PRIOR TO PLACING ONE TAXUS EXPRESS2 8.8% 2.75X16MM (LOT 7122585) DRUG ELUTING STENT WITHOUT COMPLICATION. THE DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL FOUR DAYS POST INDEX PROCEDURE RECEIVING ASA AND PLAVIX. THE SITE REPORTED THAT THE PATIENT UNDERWENT A TVR OF THE 2ND DIAGONAL ARTERY 20 DAYS POST INDEX PROCEDURE. THE PHYSICIAN TREATED THE TARGET LESION BY PLACING ONE TAXUS EXPRESS2 DRUG ELUTING STENT INTO THE VESSEL. THE PATIENT WAS REPORTED TO BE IN SATISFACTORY/GOOD CONDITION. IN THE OPINION OF THE PHYSICIAN THERE WAS A PROBABLE RELATIONSHIP BETWEEN THE TVR AND THE TAXUS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT NIQ BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 2.50 X 20 MM 7138775

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention