BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTÉ?

    MDR report key: 2983188 · Received February 28, 2013

    Report

    Report Number
    2134265-2013-01080
    Event Type
    Death
    Date Received
    February 28, 2013
    Date of Event
    January 20, 2013
    Report Date
    February 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MAF
    PMA / PMN Number
    P040016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: EXAMINATION OF THE RETURNED PRODUCT REVEALED CONTRAST IN THE INFLATION LUMEN, GUIDEWIRE LUMEN AND ON THE SHAFT AND BALLOON. THE BALLOON WAS TIGHTLY FOLDED WITH THE STENT SECURED ON THE BALLOON. THE HYPOTUBE WAS FRACTURED 33.5CM FROM THE EDGE OF THE STRAIN RELIEF. 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 REPORTED EVENT. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION CORRECTED FROM PHARMACIST TO PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-01079. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH AN EMERGENT MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA A FEMORAL ARTERY. THE DE NOVO 100% STENOSED, 4.0X10MM, CONCENTRIC TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED LEFT CORONARY TRUNK. PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON RESULTING IN 80% RESIDUAL STENOSIS. A 4.0X12MM LIBERTE STENT AND A 4.0X16MM LIBERTE STENT WERE IMPLANTED. RESISTANCE WAS NOTED DURING INSERTION OF BOTH DEVICES. IT WAS FURTHER NOTED ¿STENT WITH TORTUOSITY IN THE SUPPORT WIRE¿. POST-DILATION WAS NOT PERFORMED. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER UNKNOWN REASON. THE PATIENT EXPIRED THE NEXT DAY OF AN UNKNOWN CAUSE. HOWEVER, IT WAS NOTED THAT AN UNSPECIFIED COMORBIDITY MAY HAVE BEEN A POSSIBLE CONTRIBUTOR TO THE DEATH.

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-01079. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH AN EMERGENT MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA A FEMORAL ARTERY. THE DE NOVO 100% STENOSED, 4.0X10MM, CONCENTRIC TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED LEFT CORONARY TRUNK. PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON RESULTING IN 80% RESIDUAL STENOSIS. A 4.0X12MM LIBERTE STENT AND A 4.0X16MM LIBERTE STENT WERE IMPLANTED. RESISTANCE WAS NOTED DURING INSERTION OF BOTH DEVICES. IT WAS FURTHER NOTED "STENT WITH TORTUOSITY IN THE SUPPORT WIRE." POST-DILATION WAS NOT PERFORMED. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER UNKNOWN REASON. THE PATIENT EXPIRED THE NEXT DAY OF AN UNKNOWN CAUSE. HOWEVER, IT WAS NOTED THAT AN UNSPECIFIED COMORBIDITY MAY HAVE BEEN A POSSIBLE CONTRIBUTOR TO THE DEATH.

    Description of Event or Problem · 1

    SAME CASE AS MFR #: 2134265-2013-01079. IT WAS REPORTED THAT POST A STENTING TREATMENT PROCEDURE, THE PATIENT EXPIRED. THE PATIENT PRESENTED WITH AN EMERGENT MYOCARDIAL INFARCTION. VASCULAR ACCESS WAS OBTAINED VIA A FEMORAL ARTERY. THE DE NOVO 100% STENOSED, 4.0X10MM, CONCENTRIC TARGET LESION WAS LOCATED IN THE NON TORTUOUS AND NON CALCIFIED LEFT CORONARY TRUNK. PRE-DILATION WAS PERFORMED WITH AN UNSPECIFIED BALLOON RESULTING IN 80% RESIDUAL STENOSIS. A 4.0X12MM LIBERTE STENT AND A 4.0X16MM LIBERTE STENT WERE IMPLANTED. RESISTANCE WAS NOTED DURING INSERTION OF BOTH DEVICES. IT WAS FURTHER NOTED ¿STENT WITH TORTUOSITY IN THE SUPPORT WIRE¿. POST-DILATION WAS NOT PERFORMED. THE PROCEDURE WAS NOT COMPLETED DUE TO ANOTHER UNKNOWN REASON. THE PATIENT EXPIRED THE NEXT DAY OF AN UNKNOWN CAUSE. HOWEVER, IT WAS NOTED THAT AN UNSPECIFIED COMORBIDITY MAY HAVE BEEN A POSSIBLE CONTRIBUTOR TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88433 LIBERTÉ? STENT, CORONARY MAF BOSTON SCIENTIFIC - MAPLE GROVE H7493893816400 15271358

    Patients

    Seq Age Sex Outcome Treatment
    1 Death