BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 3073150 · Received April 23, 2013

    Report

    Report Number
    2134265-2013-02622
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A TAXUS LIBERTE STENT DELIVERY SYSTEM (SDS) WITH STENT AND SHELF BOX. THERE WAS BLOOD IN THE GUIDEWIRE LUMEN AND UNDER THE BALLOON FOLDS. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT POSITIONED 5MM PAST THE DISTAL END OF THE PROXIMAL MARKERBAND. THE FIRST TWO ROWS OF THE STRUTS ON BOTH THE PROXIMAL AND DISTAL ENDS OF THE STENT WERE BENT, FLARED AND OVERLAPPING. THE SHAFT WAS KINKED 9.5 AND 21CM FROM THE DISTAL TIP. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. ALTHOUGH IT WAS REPORTED THAT THE DEVICE WAS NOT USED, THE PRESENCE OF BLOOD IN THE GUIDEWIRE LUMEN IS INDICATIVE OF HANDLING BEYOND SIMPLY UNPACKING THE DEVICE, AS WAS REPORTED. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS COMBINATION PRODUCT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURED. THE 80% STENOSED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.5 X 12 MM TAXUS LIBERTÉ STENT WAS TO BE USED. HOWEVER, AFTER UNPACKING, THE PHYSICIAN FOUND THE SURFACE OF THE STENT WAS NOT SMOOTH SO ANOTHER OF THE SAME DEVICE WAS USED TO FINISH THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURED. THE 80% STENOSED LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 4.5 X12 MM TAXUS LIBERTÉ STENT WAS TO BE USED. HOWEVER, AFTER UNPACKING, THE PHYSICIAN FOUND THE SURFACE OF THE STENT WAS NOT SMOOTH SO ANOTHER OF THE SAME DEVICE WAS USED TO FINISH THE PROCEDURE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174799 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493894012450 15306786

    Patients

    Seq Age Sex Outcome Treatment
    1