BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTÉ?

    MDR report key: 3122797 · Received May 21, 2013

    Report

    Report Number
    2134265-2013-03344
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER - RETURNED PRODUCT CONSISTED OF A LIBERTE/VERIFLEX STENT DELIVERY SYSTEM (SDS) WITH STENT AND A SHELF BOX AND PRODUCT POUCH. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON. THERE WAS NO DAMAGE TO THE STENT. THE HYPOTUBE WAS FRACTURED 36CM FROM THE STRAIN RELIEF. THE FRACTURE FACES WERE OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THERE WERE MULTIPLE HYPOTUBE KINKS. 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 MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATION BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID ANGIOPLASTY TREATMENT PROCEDURE, A STENT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THIS 2.75X16MM LIBERTÉ STENT WAS SELECTED; HOWEVER, DURING DEPLOYMENT THERE WAS A DOUBLE FRACTURE OF THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CAROTID ANGIOPLASTY TREATMENT PROCEDURE, A STENT FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THIS 2.75X16MM LIBERTÉ STENT WAS SELECTED; HOWEVER, DURING DEPLOYMENT THERE WAS A DOUBLE FRACTURE OF THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223791 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816270 15512394

    Patients

    Seq Age Sex Outcome Treatment
    1