BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2012132 · Received March 9, 2011

    Report

    Report Number
    2134265-2011-00678
    Event Type
    Injury
    Date Received
    March 9, 2011
    Date of Event
    December 7, 2010
    Report Date
    February 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

    DESCRIBE EVENT CORRECTED LESION TREATED FROM LAD TO THE OSTIUM OF 1ST SEPTAL BRANCH. (B)(4).

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND AN OCCLUSION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 75% STENOSIS AND WAS 9.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.4 MM. THE PHYSICIAN TREATED THE TARGET LESION WITH DIRECT STENT PLACEMENT OF A 4 MM X 12 MM TAXUS LIBERTE STENT WITH 5% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND PRASUGREL. FIVE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED WITH CHEST PAIN. ANGIOGRAPHY SHOWED A PATENT STENT IN THE LAD. HOWEVER, THERE IS A FAIRLY LARGE SEPTAL BRANCH JAILED BY THE STENT AND A LONG HIGH GRADE OCCLUSION AFTER THE DIAGONAL BRANCH, NARROWING THE LUMEN BY 75%. THE DISTAL LAD WAS TREATED WITH PLACEMENT OF A 2.5 X 23 MM NON BSC STENT WITH NO RESIDUAL STENOSIS. THE RIGHT CORONARY ARTERY WAS TREATED WITH PLACEMENT OF A 2.5 X 13 MM STENT WITH NO RESIDUAL STENOSIS. SIX DAYS POST INDEX PROCEDURE, THE LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.0 X 8.0 MM NON-DRUG-COATED STENT WITH NO RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT 6 DAYS POST INDEX PROCEDURE THE OSTIUM OF 1ST SEPTAL BRANCH NOT THE LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.0 X 8.0 MM NON-DRUG-COATED STENT WITH NO RESIDUAL STENOSIS.

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED ANGINA AND AN OCCLUSION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 75% STENOSIS AND WAS 9.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.4 MM. THE PHYSICIAN TREATED THE TARGET LESION WITH DIRECT STENT PLACEMENT OF A 4 MM X 12 MM (B)(4) STENT WITH 5% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND PRASUGREL. 5 DAYS AFTER THE INDEX PROCEDURE THE PATIENT WAS ADMITTED WITH CHEST PAIN. ANGIOGRAPHY SHOWED A PATENT STENT IN THE LAD. HOWEVER, THERE IS A FAIRLY LARGE SEPTAL BRANCH JAILED BY THE STENT AND A LONG HIGH GRADE OCCLUSION AFTER THE DIAGONAL BRANCH, NARROWING THE LUMEN BY 75%. THE DISTAL LAD WAS TREATED WITH PLACEMENT OF A 2.5 X 23 MM NON BSC STENT WITH NO RESIDUAL STENOSIS. THE RIGHT CORONARY ARTERY WAS TREATED WITH PLACEMENT OF A 2.5 X 13 MM STENT WITH NO RESIDUAL STENOSIS. 6 DAYS POST INDEX PROCEDURE THE LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 2.0 X 8.0 MM NON-DRUG-COATED STENT WITH NO RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893612400 13376159

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention