BEUDAMED
    FDA Adverse Event Death Summary report: N

    TAXUS LIBERTE PACLITAXEL DRUG ELUTING STENT

    MDR report key: 732997 · Received July 6, 2006

    Report

    Report Number
    6000089-2006-01392
    Event Type
    Death
    Date Received
    July 6, 2006
    Date of Event
    December 21, 2005
    Report Date
    June 12, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. SHOULD FURTHER RELEVANT INFO BECOME AVAILABLE; A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CLINICAL STUDY. SDG SAME CASE AS 6000089-2006-01391. IT WAS REPORTED THAT 211 DAYS AFTER A CORONARY ARTERY DRUG-ELUTING STENTING TREATMENT PROCEDURE, THE PT EXPIRED. THE INDEX PROCEDURE TREATED 2 DE NOVO TARGET LESIONS. TARGET LESION 1 WAS AN OSTIAL LESION, 2.5MM VESSLE DIAMETER, 18MM LONG, WITH SEVERE CALCIFICATION, MILD TORTUOSITY, AND 90% STENOSIS, IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS PREDILATED WITH A ROTABLATOR AND THE PHYSICIAN IMPLANTED 1 TAXUS LIBERTE 2.5X20MM DRUG-ELUTING STENT (DES). TARGET LESION 2 (13 MM) WAS IDENTIFIED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS AND A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE MID RCA WAS DILATED WITH A 2.0 X 16 MM BALLOON AND TREATED WITH A 3.0 X 16 MM TAXUS LIBERTE STENT WITH 1% STENOSIS. THE PT WAS DISCHARGED 1 DAY LATER ON ASA AND PLAVIX. "DURING THE 12-MONTH TELEPHONE CALL, THE PT'S WIFE REPORTED THAT THE PT DIED IN 2005. ACCORDING TO THE PT'S SON ( A PHYSICIAN) THE PT WAS ADMITTED TO THE HOSP AND UNDERWENT CARDIAC CATHETERIZATION REVEALING "PERMEABLE STENTS" (PER TRANSLATED SOURCE DOCUMENTS)." MEDICAL TREATMENT WAS INDICATED. "THE FOLLOWING WAS CONCLUDED AS CAUSE OF DEATH: ACUTE RENAL FAILURE, WATER-ELECTROLYTE IMBALANCE." THE PHYSICIAN INDICATED THE DEATH WAS NOT RELATED TO THE STENT. THE TAXUS LIBERTE STENT THAT WAS IMPLANTED WAS USED BEYOND THE EXPIRATION DATE. THIS PRODUCT IS ONLY OUS APPROVED, BUT IT IS SIMILAR TO A MARKETED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL DRUG ELUTING STENT DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC CORP. 3.0X16MM 6999442

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death