BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3180544 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04484
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    April 26, 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

    CORRECTION: DEVICE LOT NUMBER: FROM 15213324 TO 15789076. DEVICE EXPIRATION DATE: FROM 04/30/2015 TO 01/09/2016. DEVICE MANUFACTURED DATE: FROM 05/02/2012 TO 01/11/2013. DEVICE EVALUATED BY MFR.: RETURNED PRODUCT CONSISTED OF A LIBERTE/VERIFLEX STENT DELIVERY SYSTEM (SDS) WITH STENT AND THE ORIGINAL SHELF BOX, INNER POUCH AND CARRIER TUBE (HOOP. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON BETWEEN THE MARKERBANDS. MAGNIFIED AND VISUAL INSPECTION CONFIRMED THERE WAS NO DAMAGE TO THE STENT. THE HYPOTUBE WAS SEPARATED 49.5CM FROM THE EDGE OF THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THE DISTAL TIP WAS DAMAGED. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES. 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 2.50MM X 12MM 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 2.50MM X 12MM 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
    281182 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893812250 15789076

    Patients

    Seq Age Sex Outcome Treatment
    1