BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 601551 · Received May 10, 2005

    Report

    Report Number
    6000089-2005-00731
    Event Type
    Death
    Date Received
    May 10, 2005
    Date of Event
    April 20, 2005
    Report Date
    April 21, 2005
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 412 DAYS AFTER THE FIRST OF TWO STAGED CORONARY ARTERY DRUG ELUTING STENTING PROCEDURES THE PT EXPIRED. THE FIRST PROCEDURE TREATED THREE TARGET LESIONS. THE SECOND PROCEDURE TREATED ONE TARGET LESION AND WAS PERFORMED 4 DAYS LATER. TARGET LESION 1 WAS A 2.5 MM VESSEL DIAMETER, 85% STENOSED REGION OF THE RIGHT POSTERIOR DESCENDING ARTERY (R-PDA). THE PHYSICIAN TREATED THIS LESION BY DIRECT STENTING WITH ONE TAXUS EXPRESS2 8.8% 2.5X12 MM (LOT 6071692) DRUG ELUTING STENT WITHOUT COMPLICATION. TARGET LESION 2 WAS A 3.5 MM VESSEL DIAMETER, 90% STENOSED REGION OF THE MID RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN PREDILATED THE LESION BEFORE SUCCESSFULLY PLACING ONE TAXUS EXPRESS2 8.8% 3.0X24 MM (LOT 6077002) DRUG ELUTING STENT WITHOUT COMPLICATION. TARGET LESION 3 WAS A 4.0 MM VESSEL DIAMETER, 60% STENOSED REGION OF THE PROXIMAL RCA. THE PHYSICIAN TREATED THIS LESION BY DIRECT STENTING WITH ONE TAXUS EXPRESS2 8.8% 3.5X8 MM (LOT 6092133) DRUG ELUTING STENT WITHOUT COMPLICATION. THIS DRUG ELUTING STENT WAS POST DILATED AFTER DEPLOYMENT. TARGET LESION 4 (PROCEDURE 2) WAS A 2.5 MM VESSEL DIAMETER, 99% STENOSED BIFURCATED REGION OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS IS AN OSTIAL LESION. THE PHYSICIAN TREATED THE LESIO BY PERFORMING THE KISSING BALLOON TECHNIQUE SUCCESSFULLY PLACING ONE TAXUS EXPRESS2 8.8% 2.5X12 MM (LOT 6071692) DRUG ELUTING STENT INTO THE TARGET VESSEL WITHOUT COMPLICATION. THE PT WAS DISCHARGED FROM THE HOSPITAL 6 DAYS AFTER THE FIRST PROCEDURE RECEIVING ASA, LIPITOR, AND PLAVIX. THE SITE REPORTED THAT THE PT EXPIRED 412 DAYS AFTER THE INITIAL INDEX PROCEDURE. THE REPORTED CAUSE OF DEATH WAS SEPTIC SHOCK POST MITRAL VALVE REPAIR.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT TARGET LESION WAS 10.0 MM IN LENGTH AND HAD 0% RESIDUAL STENOSIS AFTER IMPLANTATION. TARGET LESION 2 WAS 24.0 MM IN LENGTH AND HAD 0% RESIDUAL STENOSIS AFTER POST-DILITATION. TARGET LESION 3 WAS 5.0 MM IN LENGTH AND HAD 0% RESIDUAL STENOSIS AFTER POST-DILITATION. RECOMMENDATION WAS MADE FOR STAGED PROCEDURE TO THE LAD THE FOLLOWING WEEK. PER CARDIAC CATHETERIZATION REPORT FROM DATE OF THE INDEX PROCEDURE, THE PT WOULD ALSO REQUIRE FUTURE PTA STENTING OF THE RIGHT RENAL ARTERY (99% STENOSIS) AND POSSIBLY THE DISTAL AORTA. TARGET LESION 4 WAS 4.0 MM IN LENGTH. THIS (STENTING OF TARGET LESION 4) RESULTED IN JAILING OF THE OSTIAL ST DIAGONAL, WHICH DID NOT PREVIOUSLY SHOW ANY OBSTRUCTION. THE OSTIAL ST DIAGONAL WAS TREATED WITH BALLOON ANGIOPLASTY FOLLOWED BY SIMULTANEOUS BALLOON ANGIOPLASTY OF THE PROXIMAL LAD (USING THE STENT BALLOON) AND THE ST DIAGONAL PER KISSING BALLOON TECHNIQUE. FINAL ANGIOGRAPY SHOWED BOTH SEGMENTS TO BE WIDELY PATENT. THE PT WAS NOTED TO BE IN ATRIAL FIBRILLATION THROUGHOUT THE PROCEDURE. SHE WAS STARTED ON AMIODARONE HYDROCHLORIDE THERAPY POST PROCEDURE WITH CONVERSION TO NORMAL SINUS RHYTHM. THE PT WAS ADMITTED FOR MITRAL VALVE REPLACEMENT SURGERY 322 DAYS POST INDEX PROCEDURE. CORONARY ANGIOGRAPHY 231 DAYS POST INDEX PROCEDURE REVEALED NO SIGNIFICANT IN-STENT RESTENOSIS OF THE PREVIOUSLY STENTED RCA, R-PDA, OR LAD. THE PT WAS NOTED TO HAVE SEVERE MITRAL REGURGITATION, AND SURGICAL CONSULTATION WAS REQUESTED. THE PT UNDERWENT RECOMMENDED MITRAL VALVE REPAIR WITH A 26MM ANNULOPLASTY 322 DAYS POST INDEX PROCEDURE. POST PROCEDURE, THE PT EXPERIENCED RESPIRATORY FAILURE AND WAS PLACED ON ASSISTED MECHANICAL VENTILATION. THE PT DEVELOPED ACUTE OLIGURIC RENAL FAILURE SECONDARY TO ISCHEMIC ACUTE TUBULAR NECROSIS AND SEPSIS (GRAM POSITIVE BACTEREMIA) 332 DAYS POST INDEX PROCEDURE. THE PT WAS TREATED WITH FLUIDS AND BROAD SPECTRUM ANTIBIOTICS. HEMODIALYSIS WAS CONSIDERED A FUTURE OPTION. A TRACHEOSTOMY TUBE WAS PLACED DUE TO CONTINUED VENTILATOR DEPENDENCE, 341 DAYS POST INDEX PROCEDURE. THE PT WAS SUBSEQUENTLY TRANSFERRED TO A REHABILITATION FACILITY (DATE UNK) FOR CONTINUED MANAGEMENT. A FAMILY DECISION WAS MADE TO DISCONTINUE LIFE SUPPORT MEASURES AFTER APPROXIMATELY TWO MONTHS. THE PT WAS REMOVED FROM THE RESPIRATOR AND EXPIRED 412 DAYS POST INDEX PROCEDURE. AN AUTOPSY WAS NOT PERFORMED. CAUSE OF DEATH WAS "SEPSIS." IN THE OPINION OF THE DR THE TARGET VESSELS WERE NOT INVOLVED IN THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM DRUG COATED STENT MAF BOSTON SCIENTIFIC TAXUS EXPRESS2 8.8% 3.00 X 24 MM 6077002

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death