BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1000412 · Received February 20, 2008

    Report

    Report Number
    2134265-2008-00490
    Event Type
    Injury
    Date Received
    February 20, 2008
    Date of Event
    January 14, 2008
    Report Date
    January 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    PMA / PMN Number
    P030025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #2134265-2008-00491. IT WAS REPORTED BY THE PATIENT THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE, VESSEL OCCLUSION OCCURRED. THE PT REPORTED THAT "HE HAD AN ELEVATED BLOOD PRESSURE ON FOLLOW UP AND WAS HOSPITALIZED". HE REPORTED THAT "HE HAS OTHER TAXUS EXPRESS2 DRUG ELUTING STENTS (DES), BUT THIS PARTICULAR LEFT ANTERIOR DESCENDING ARTERY (LAD) STENT WAS FOUND TO BE 100% BLOCKED DURING THE PROCEDURE." ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT'S PHYSICIAN REPORTS THAT THE 70% STENOSED TARGET LESION WAS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 2.0X20MM MAVERICK BALLOON. A 2.5X24MM TAXUS EXPRESS2 DRUG ELUTING STENT WAS DEPLOYED IN THE TARGET LESION AT 11 ATMOSPHERES (ATMS) FOR 30 SECONDS (SECS). THERE WAS NO RESIDUAL STENOSIS NOTED AND NO PATIENT COMPLICATIONS REPORTED. AT 200 DAYS LATER, A 2.5X12MM TAXUS EXPRESS2 DES WAS DEPLOYED IN THE MID LAD AT 17 ATMS FOR 10 SECS TO TREAT AN UNSPECIFIED LESION. THERE WAS NO RESIDUAL STENOSIS NOTED AND NO PATIENT COMPLICATIONS REPORTED. AT 347 DAYS LATER, IN A CONSULTATION WITH HIS PHYSICIAN, THE PT COMPLAINED OF HAVING EPISODES OF CHEST PAIN WITH ELEVATED BLOOD PRESSURE, INCREASED DYSPNEA AS WELL AS EXERTIONAL ANGINA. TWO DAYS LATER, UNSUCCESSFUL ATTEMPTS WERE MADE TO CROSS THE "CHRONIC, OLD TOTAL MID-LAD OCCLUSION" WITH A 180CM LUGE GUIDEWIRE AND A CHOICE PT GUIDEWIRE. THE DECISION WAS MADE TO END THE PROCEDURE WITH NO PT COMPLICATIONS REPORTED. THE PT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION ON THE FOLLOWING MEDICATIONS: RANEXA 500MG DAILY, LISINOPRIL 2.5MG DAILY, TRAZODONE 200MG AT BEDTIME, LIPITOR 80MG AT BEDTIME, ASPIRIN 325MG DAILY, DOCUSATE SODIUM 100MG TWICE A DAY, OMEPRAZOLE 20MG DAILY, PLAVIX 75MG DAILY, SERTRALIN 100MG 2 TABLETS DAILY, SOTALOL 120MG TWICE A DAY, VITAMIN 5 DAILY, WELLBUTRIN 200MG TWICE A DAY, HYDROCODONE 5/500 AS NEEDED EVERY 6 HOURS AS NEEDED FOR PAIN. THE PT IS ON MEDICAL MANAGEMENT AS TREATMENT OF HIS KNOWN CORONARY ARTERY DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM NIQ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC 2.5X12MM 8818445

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other| R