BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS EXPRESS2 PACLITAXEL ELUTING STENT

    MDR report key: 734765 · Received June 27, 2006

    Report

    Report Number
    6000089-2006-01325
    Event Type
    Malfunction
    Date Received
    June 27, 2006
    Date of Event
    February 20, 2006
    Report Date
    June 6, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS REC'D IN TWO SECTIONS AS A RESULT OF A BREAK IN THE HYPOTUBE. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND A BREAK OCCURRED IN THE HYPOTUBE AT APPROX 19CM DISTAL TO THE STRAIN RELIEF. A KINK WAS NOTED IN THE WIRE LUMEN. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON AND STENT FOUND NO ISSUES. ATTEMPTED TO INSERT THE RECOMMENDED GUIDEWIRE INTO THE WIRE LUMEN OF THE DEVICE WHEN IT MET WITH A RESTRICTION AT APPROX 6.9CM PROXIMAL TO THE TIP. THIS RESTRICTION IS CONSISTENT WITH A KINK IN THE WIRE LUMEN. THE SHOP FLOOR PAPERWORK WAS REVIEWED FOR THIS PARTICULAR BATCH OF DEVICES (7987383 TOP ASSEMBLY & 7840656 MANIFOLD) AND NO ANOMALIES WERE NOTED FROM THIS REVIEW THAT COULD CORRELATE TO THE DIFFICULTIES THAT WERE EXPERIENCED BY THE PHYSICIAN DURING THE USE OF THIS PRODUCT. THE ROOT CAUSE OF THIS COMPLAINT IS UNK.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 6/6/2006. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STENT COULD NOT CROSS THE LESION. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT THE SHAFT OF THE CATHETER HAD FRACTURED. THE INDEX PROCEDURE TREATED A 90% STENOSED, SEVERELY TORTUOUS, MODERATELY CALCIFIED, DE NOVO LESION LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE PHYSICIAN ADVANCED A TAXUS EXPRESS2 2.25 X 16MM STENT TO THE LESION, HOWEVER, THE STENT WOULD NOT CROSS THE LESION. UPON EXAMINATION OF THE DEVICE, THE CATHETER HAD FRACTURED. THE PROCEDURE WAS ABANDONED. THERE WERE NO REPORTED PT COMPLICATIONS. THE PT'S STATUS WAS INDICATED AS "SATISFIED/GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS EXPRESS2 PACLITAXEL ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORPORATION 2.25 X 16MM 7987383

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR