BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2061181 · Received April 18, 2011

    Report

    Report Number
    2134265-2011-01258
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 31, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND AND MET ALL 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)(4).

    Description of Event or Problem · 1

    IT WAS PREVIOUSLY REPORTED THAT THE TARGET LESION WAS THE 2ND DIAGONAL BRANCH, UPDATED INFORMATION STATES THE TARGET LESION WAS THE 3RD DIAGONAL BRANCH. IN (B)(6) 2011, UPON ADMITTANCE WITH ANGINA PECTORIS, CARDIAC ENZYMES WERE NEGATIVE. THE CEC HAS ADDED AN EVENT OF MYOCARDIAL INFARCTION FOR THIS PATIENT. PER THE PHYSICIAN, THE EVENT RELATION TO THE EVENT WAS LISTED AS "PROBABLE."

    Description of Event or Problem · 1

    TAXUS LIBERTE CLINICAL STUDY. IT WAS REPORTED THAT FOLLOWING A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT PRESENTED WITH ANGINA PECTORIS. THE INDEX PROCEDURE TREATED THE 80% STENOSED, 2.2X5.0MM TARGET LESION LOCATED IN THE 2ND DIAGONAL BRANCH. THE TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.25X12 MM TAXUS LIBERTE STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT WAS ADMITTED WITH ANGINA PECTORIS AND CARDIAC CATHETERIZATION WAS RECOMMENDED. SOURCE NOTES THE PATIENT HAD BEEN NONCOMPLIANT WITH MEDICATIONS FOR THE PREVIOUS FEW WEEKS. THE NEXT DAY, IN-STENT RESTENOSIS WAS DIAGNOSED IN THE 3RD DIAGONAL BRANCH AND WAS TREATED WITH BALLOON ANGIOPLASTY USING A 2.25 X 12MM MAVERICK BALLOON RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT EXPERIENCED POST PROCEDURAL ELEVATION OF CARDIAC ENZYMES AS WELL AS CHEST DISCOMFORT. THE SUBJECT ALSO EXPERIENCED AN EPISODE OF SOME NUMBNESS ON THE LEFT SIDE OF HIS FACE AND HIS LEFT UPPER EXTREMITY, PARTICULARLY HIS HAND. THREE DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR