BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 617474 · Received June 24, 2005

    Report

    Report Number
    6000093-2005-00709
    Event Type
    Injury
    Date Received
    June 24, 2005
    Date of Event
    May 24, 2005
    Report Date
    May 25, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 399 DAYS AFTER A CORONARY ARTERY DRUG ELUTING STENTING PROCEDURE THE PATIENT UNDERWENT A TARGET VESSEL REINTERVENTION (TVR) TO THE SAPHENOUS VEIN GRAFT (SVG) OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE INDEX PROCEDURE TREATED ONE TARGET LESION. TARGET LESION 1 WAS A 3.5 MM VESSEL DIAMETER, 70% STENOSED OSTIAL REGION OF THE SVG OF THE PROXIMAL LAD. THE PROCEDURE WAS PERFORMED TO ALLEVIATE IN-STENT RESTENOSIS FROM A PREVIOUSLY PLACED STENT. THE PHYSICIAN PREDILATED THE LESION PRIOR TO PLACING ONE TAXUS EXPRESS2 8.8% 3.5X20MM (LOT) 6150467) DRUG ELUTING STENT WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ONE DAY POST INDEX PROCEDURE RECIEVING LIPITOR, PLAVIX, AND ASA. THE SITE REPORTED THAT THE PATIENT UNDERWENT A TVR TO THE SVG OF THE PROXIMAL LAD TO ALLEVIATE PROXIMAL EDGE AND FOCAL IN-STENT RESTENOSIS 399 DAYS POST INDEX PROCEDURE. THE PHYSICIAN TREATMENT THE LESION BY PLACING ONE TAXUS STENT IN THE TARGET VESSEL. THE PATIENT WAS DISCHARGE FROM THE HOSPITAL ONE DAY POST TVR.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE LIMA TO THE PROXIMAL LAD GRAFT. THE TARGET LESION WAS 18.0 MM IN LENGTH. THE TAXUS STENT WAS PLACED "CREATING A STENT SANDWICH OF THE LIMA ORIGIN." RESIDUAL STENOSIS WAS 0% AFTER DEPLOYMENT. THE PT PRESENTED 399 DAYS POST ARRIVE ENROLLMENT WITH RECURRENT UNSTABLE ANGINA AT REST AND A POSTIVE THALLIUM STRESS TEST. CARDIAC CATHETERIZATION REVEALED THAT THE RCA WAS TOTALLY OCCLUDED WITH GRAFT DEPENDENCY, THE LAD HAD DIFFUSE 30-40% IRREGULARITIES WITH "COMPETITIVE FILLING" FROM THE IMA, AND THE LCX HAD 50% STENOSIS OF THE OB MARG "CONSIDERED TO BE NON-CRITICAL." THE LIMA TO LAD HAD 80% OSTIAL STENOSIS. A 2.5 X 20MM TAXUS STENT WAS DEPLOYED IN THE OSTIUM OF THE IMA TO THE LAD, 399 DAYS POST INDEX PROCEDURE. RESIDUAL STENOSIS WAS 0%. OF NOTE, "NO EFFORTS WERE MADE AT ANGIOPLASTY OF THE PREVIOUSLY STENTED AND OCCLUDED RCA IN VIEW OF THE FACT THAT THE SVG TO THE RCA WAS NORMAL." THE PT WAS DISCHARGED ON ASA AND PLAVIX. IN THE OPINION OF THE PHYSICIAN THERE WAS A PROBABLE RELATIONSHIP BETWEEN THE EVENT 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% 3.50 X 20 MM 6150467

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention