BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT

    MDR report key: 757799 · Received September 5, 2006

    Report

    Report Number
    6000093-2006-01751
    Event Type
    Death
    Date Received
    September 5, 2006
    Date of Event
    February 2, 2006
    Report Date
    August 10, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PATIENT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. BECAUSE THE BATCH NUMBER FOR THIS COMPLAINT IS UNKNOWN, THE SHOP FLOOR PAPERWORK COULD NOT BE EXAMINED. THE CAUSE OF THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    CLINICAL STUDY. IT WAS REPORTED THAT 262 DAYS AFTER A CORONARY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE INDEX PROCEDURE TREATED 1 DE NOVO TARGET LESION LOCATED IN THE MID RIGHT CORONARY ARTERY. THE LESION WAS PREDILATED WITH AN ANGIOPLASTY BALLOON AT 12 ATMS. THE PHYSICIAN SUCCESSFULLY IMPLANTED A 30X32MM TAXUS EXPRESS2 DRUG-ELUTING STENT AT 14 ATMS. THE PATIENT WAS DISCHARGED 2 DAYS LATER ON ASPIRIN AND PLAVIX. THE PATIENT EXPIRED 262 DAYS POST-INDEX PROCEDURE. THE NIGHT BEFORE HIS DEATH, THE PATIENT WAS ADMITTED AMBULATORY TO THE EMERGENCY ROOM WITH "PMH AFIB, CAD, COPD" COMPLAINING OF NOSE BLEEDING FOR TWO DAYS. "HE IS UNABLE TO DESCRIBE THE AMOUNT, BUT DID SOAK HIS SHIRT. HE HAS HAD NO BLEEDING FOR > 12 HOURS. HE C/O SOME DIZZINESS WHEN STANDING FOR THE LAST 2 DAYS. HE DENIES ANY PAIN/SOB. HE HAS HAD SOME PALPITATIONS. HE HAD A RECENT HOSP ADMIT FOR AFIB WITH RVR AND WAS STARTED ON COUMADIN. HE HAS STOPPED ALL OF HIS MEDICINES FOR THE LAST 2 DAYS BECAUSE HIS IS CONFUSED ABOUT WHAT HE IS SUPPOSED TO TAKE. HE HAS NOT HAD COUMADIN, METOPROLOL, OR DIG FOR 2 DAYS. HE IS NOT ORTHOSTATIC." "NO BLOOD IN NOSE OR OP." HIS TEMPERATURE WAS 96.4, PULSE WAS 102, RESPIRATIONS 18, AND BLOOD PRESSURE (BP) WAS 98/83. THE PATIENT WAS TAKING A CONSIDERABLE AMOUNT OF MEDICATIONS. "HE HAS NOT HAD ANY BLEEDING FOR >12 HOURS, HCT IS STABLE, INR 3.68, AND HE HAS NOT HAD COUMADIN IN 2 DAYS. HE NEEDING COUMADIN WITH AFIB TO PREVENT CVA AND LIKELY HAS BLEEDING BECAUSE INR >3." LATER, THE PATIENT'S HEART RATE WAS 80 AND BP WAS 105/63. "HE FEELS BETTER NOW WITH NO BLEEDING." THE PATIENT WAS DISCHARGED WITH FOLLOW-UP FOR PCP IN 1 WEEK AND 2 DAYS FOR INR. THE PATIENT EXPIRED THE FOLLOWING DAY. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING STENT DRUG COATED STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X32MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death