BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2230480 · Received September 1, 2011

    Report

    Report Number
    2134265-2011-03702
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: 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).

    Additional Manufacturer Narrative · 1

    RELEVANT TESTS UPDATED.(B)(4).

    Description of Event or Problem · 1

    (B)(6). SAME CASE AS 2134265-2011-03703. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN. LESION 1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.5 X 16 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. LESION 2 WAS LOCATED IN THE DISTAL LAD WITH 99% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.5 X 16 MM TAXUS LIBERTE STENT AND POST DILATATION WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED (B)(6) POST PROCEDURE ON ASPIRIN AND PRASUGREL (B)(6) POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH CARDIAC CHEST PAIN AND WAS ADMITTED TO THE HOSPITAL. (B)(6) LATER THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL UNIT FOR FURTHER EVALUATION AND TREATMENT. THE PATIENT WAS TRANSFERRED FOR DIRECT ADMIT TO TELEMETRY FOR HIS CHEST PAIN. CARDIAC CATHETERIZATION WAS RECOMMENDED. (B)(6) LATER THE PATIENT UNDERWENT A VESSEL REVASCULARIZATION OF THE DISTAL LAD AND CORONARY ARTERY BYPASS GRAFTING OF THE TARGET VESSEL WAS PERFORMED. THE PATIENT WAS DISCHARGED (B)(6) LATER.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT AT THE TIME OF THE EVENT THE PATIENT HAD A 2 DAY HISTORY OF RADIATING RETROSTERNAL CHEST PAIN.

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS 2134265-2011-03703. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED CHEST PAIN. LESION 1 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 3.5 X 16 MM (B)(4) STENT WITH 0% RESIDUAL STENOSIS. LESION 2 WAS LOCATED IN THE DISTAL LAD WITH 99% STENOSIS AND WAS 10 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND IMPLANTING A 2.5 X 16 MM (B)(4) STENT AND POST DILATATION WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED 2 DAYS POST PROCEDURE ON ASPIRIN AND PRASUGREL 141 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH CARDIAC CHEST PAIN AND WAS ADMITTED TO THE HOSPITAL. 7 DAYS LATER THE PATIENT WAS TRANSFERRED TO ANOTHER MEDICAL UNIT FOR FURTHER EVALUATION AND TREATMENT. THE PATIENT WAS TRANSFERRED FOR DIRECT ADMIT TO TELEMETRY FOR HIS CHEST PAIN. CARDIAC CATHETERIZATION WAS RECOMMENDED. 10 DAYS LATER THE PATIENT UNDERWENT A VESSEL REVASCULARIZATION OF THE DISTAL LAD AND CORONARY ARTERY BYPASS GRAFTING OF THE TARGET VESSEL WAS PERFORMED. THE PATIENT WAS DISCHARGED 8 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS (R) LIBERTÉ (R) CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893716350 13610137

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention 2.50X16MM TAXUS LIBERTE STENT