BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3180498 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04480
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A LIBERTE/VERIFLEX STENT DELIVERY SYSTEM (SDS) WITH BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. THERE WERE MULTIPLE ROWS OF STENT STRUTS THAT WERE FLARED, OVERLAPPING AND BENT. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL. A TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00MM X 32MM LIBERTÉ¿ STENT DELIVERY SYSTEM WAS USED TO TREAT THE LESION. UPON INSERTION TO THE LESION, THE DEVICE COULD NOT PASS AND THE STENT WAS THEN DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY TREATMENT PROCEDURE A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL. A TARGET LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.00MM X 32MM LIBERTÉ STENT DELIVERY SYSTEM WAS USED TO TREAT THE LESION. UPON INSERTION TO THE LESION, THE DEVICE COULD NOT PASS AND THE STENT WAS THEN DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280005 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893832300 15744902

    Patients

    Seq Age Sex Outcome Treatment
    1