BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS® LIBERTÉ®

    MDR report key: 2943935 · Received February 5, 2013

    Report

    Report Number
    2134265-2013-00268
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: JAN 2013. PATIENT IDENTIFIER: (B)(6). DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFORMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATION AS THE REPORTED EVENT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE PRODUCT DIRECTIONS FOR USE (DFU) AND/OR DEVICE LABELING. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. SAME CASE AS MDR ID#: 2134265-2013-00267. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT HAD ANGINA AND REQUIRED A TARGET VESSEL REVASCULARIZATION (TVR). IN (B)(6) 2010, THE PATIENT PRESENTED WITH COMPLAINTS OF SYNCOPE AND WAS DIAGNOSED WITH SILENT ISCHEMIA AND RECURRENT ANGINA. CARDIAC CATHETERIZATION WAS RECOMMENDED. THE DE NOVO 1ST TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL BRANCH (OM1) WITH 80% STENOSIS AND WAS 32MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATION AND PLACEMENT OF A 3.00X38MM TAXUS LIBERTE STENT, WITH 10% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE DE NOVO 2ND TARGET LESION WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (DIST LAD) WITH 80% STENOSIS AND WAS 32MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 3.00X38MM TAXUS LIBERTE STENT, WITH 10% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE DE NOVO 3RD TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MID LAD) WITH 80% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE PHYSICIAN TREATED THE LESION WITH DIRECT PLACEMENT OF A 3.00X20MM TAXUS LIBERTE STENT, WITH 10% RESIDUAL STENOSIS FOLLOWING POST-DILATION. THE STENTS IN THE LAD WERE DEPLOYED IN AN OVERLAPPING FASHION. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2012, THE PATIENT HAD IN-STENT RESTENOSIS OF THE STUDY STENTS IN THE LAD, WHICH WAS TREATED WITH PLACEMENT OF THREE NON-BSC STENTS DEPLOYED IN OVERLAPPING MANNER FROM PROXIMAL TO DISTAL LAD. IN (B)(6) 2013, THE PATIENT PRESENTED WITH COMPLAINTS OF RECURRENT AND ESCALATING CHEST PAIN, CONTINUING FOR THE PAST THREE DAYS. THE PATIENT WAS HOSPITALIZED ON THE SAME DAY. AT THE TIME OF THE EVENT, THE PATIENT WAS ON LOW DOSE ASPIRIN ONLY. THE PATIENT HAD DISCONTINUED THE STUDY MEDICATION TWO WEEKS PRIOR TO THE EVENT. AN INTERRUPTION WAS NOTED IN THE MID SEGMENT OF THE DISTAL 38MM NON-BSC STENT IN THE LAD WHICH WAS SUGGESTIVE OF STRUT FRACTURE. THE UNSUPPORTED SEGMENT OF LAD BETWEEN THE TWO STRUT SEGMENTS WAS NOTED TO BE SOMEWHAT NARROWED. 80% STENOSIS WAS NOTED IN THE MID LAD AND WAS TREATED WITH A 3.5X12MM NON-BSC DRUG ELUTING STENT. RESIDUAL STENOSIS WAS LESS THAN 10% FOLLOWING POST DILATION. THE EVENT WAS CONSIDERED AS RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48260 TAXUS® LIBERTÉ® CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493893620300 0013315929

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R