BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTÉ¿

    MDR report key: 2830908 · Received November 13, 2012

    Report

    Report Number
    2134265-2012-06857
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: VISUAL INSPECTION OF THE RETURNED PRODUCT REVEALED THE PRODUCT CONSISTED OF A LIBERTE/VERIFLEX STENT DELIVERY SYSTEM (SDS) WITH THE ORIGINAL SHELF BOX, INNER POUCH AND CARRIER TUBE (HOOP). CONTRAST WAS PRESENT WITH BLOOD IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS TIGHTLY FOLDED WITH STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBAND. THE SHAFT HAD EXTENSIVE DAMAGE TO THE INNER AND DISTAL OUTERS. THE DISTAL TIP WAS DAMAGED. WHEN POSITIVE PRESSURE WAS APPLIED WITH AN INFLATION DEVICE FILLED WITH WATER, THE DEVICE LEAKED FROM THE PORT WELD AREA. FURTHER INVESTIGATION REVEALED THAT THE INNER SHAFT WAS SEPARATED 4 MM FROM THE GUIDE WIRE EXIT NOTCH. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THERE WAS NO EVIDENCE OF ANY MATERIAL OR MANUFACTURING DEFICIENCIES CONTRIBUTING TO THE DAMAGE. THE SHAFT SEPARATION LIKELY CONTRIBUTED TO THE INFLATION AND DEPLOYING DIFFICULTIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS INVESTIGATION IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DID NOT FULLY DEPLOY. THE NEARLY TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS, NON-CALCIFIED OSTIAL RIGHT CORONARY ARTERY. THE 24MM 3.50 LIBERTE BARE METAL STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND PARTIALLY INFLATED. THE STENT WAS INFLATED TO ABOUT 1.5MM IN DIAMETER BUT AT THAT POINT IT WOULD INFLATE NO MORE. THE SDS WAS REMOVED. ANOTHER BALLOON WAS ABLE TO CROSS THE LESION AND POST-DILATE THE STENT TO THE DESIRED DIAMETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A STENT DID NOT FULLY DEPLOY. THE NEARLY TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS, NON-CALCIFIED OSTIAL RIGHT CORONARY ARTERY. THE 24MM 3.50 LIBERTE BARE METAL STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND PARTIALLY INFLATED. THE STENT WAS INFLATED TO ABOUT 1.5MM IN DIAMETER BUT AT THAT POINT IT WOULD INFLATE NO MORE. THE SDS WAS REMOVED. ANOTHER BALLOON WAS ABLE TO CROSS THE LESION AND POST-DILATE THE STENT TO THE DESIRED DIAMETER. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTÉ¿ STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893824350 15408056

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention