BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTE' MONORAIL STENT DELIVERY SYSTEM

    MDR report key: 765694 · Received September 27, 2006

    Report

    Report Number
    6000093-2006-01952
    Event Type
    Injury
    Date Received
    September 27, 2006
    Date of Event
    July 20, 2006
    Report Date
    August 28, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MAF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT WAS IMPLANTED AND THE COMPLAINT INDICATED THAT THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVALUATION; 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. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 6900969 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. THERE ARE NO SIMILAR COMPLAINTS OF THIS NATURE RELATED TO THIS BATCH NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, THERE WAS A RESTENOSIS. THE PHYSICIAN IMPLANTED A 16MM X 2.50MM LIBERTE' MONORAIL STENT IN THE RIGHT CORONARY ARTERY (RCA). TWO MONTHS, 5 DAYS POST PROCEDURE, THERE WAS A RESTENOSIS OF THE LIBERTE' STENT WHICH WAS TREATED WITH A TAXUS EXPRESS2 DRUG ELUTING STENT. NO PT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTE' MONORAIL STENT DELIVERY SYSTEM CORONARY STENT SYSTEM MAF BOSTON SCIENTIFIC 16MM X 2.50MM 6900969

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention