BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS (R) LIBERTÉ (R)

    MDR report key: 2220975 · Received August 23, 2011

    Report

    Report Number
    2134265-2011-03453
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    January 12, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM.THE RIGHT CORONARY ARTERY WAS CORRECT FROM 80% DISTAL STENOSIS TO 85% DISTAL STENOSIS.(B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. (B)(6). DEVICE EVALUATED BY MANUFACTURER - THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2011, AT THE PROXIMAL EDGE OF THE 3.0X32MM TAXUS LIBERTE STENT THERE WAS SOME DISEASE WITH ADDITIONAL SPASM. THE VESSEL WAS EVALUATED WITH INTRAVASCULAR ULTRASOUND (IVUS) AND A 3.5X8MM TAXUS LIBERTE STENT WAS PLACED OVERLAPPING THE PROIXMAL EDGE OF THE FIRST STENT.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2011-03414, SAME CASE AS: 2134265-2011-01293. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED MYOCARDIAL INFARCTION. LESION 1 WAS LOCATED IN THE 1ST OBTUSE MARGINAL. THE LESION WAS 99% STENOSED, 3.0MM IN DIAMETER AND 8MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 3.0X24MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 10%. LESION 2 WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX). THE LESION WAS 85% STENOSED, 2.5MM IN DIAMETER AND 15MM LONG. THE LESION WAS TREATED WITH DIRECT STENT PLACEMENT OF A 2.5X32MM AND 2.75X12MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. PER SOURCE NOTES, TARGET LESION 2 WAS LOCATED IN THE MID LCX. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND PRASUGREL. DURING THE INDEX, IT WAS NOTED THAT THE PATIENT EXPERIENCED CHEST PAIN WITH BALLOON INFLATION AFTER PLACEMENT OF THE 2.5X32MM TAXUS LIBERTE STENT IN THE MID LCX. ELECTROCARDIOGRAM (ECG) INDICATED ST ELEVATION IN THE INFERIOR LEAD. THE PATIENT WAS TREATED WITH NITROGLYCERIN. THE CHEST DISCOMFORT/PAIN AND ECG CHANGES WERE ULTIMATELY RESOLVED. 1 DAY LATER THE PATIENT EXPERIENCED CHEST PAIN AND INFERIOR ST ELEVATION REQUIRING MORE ANGIOS AND BALLOON INFLATIONS. CARDIAC ENZYMES WERE ELEVATED TO MYOCARDIAL INFARCTION (MI). THE EVENT SUBSEQUENTLY RESOLVED. IN (B)(6) 2011, A STAGED PROCEDURE WAS PERFORMED. THE LESION BEING TREATED WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS 85% STENOSED, 3.2MM IN DIAMETER AND 15MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF OVERLAPPING 3.0X32MM AND 3.5X8MM TAXUS LIBERTE STENTS. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. PER THE INVESTIGATOR, THE MYOCARDIAL INFARCTION WAS NOT RELATED TO THE TAXUS STENTS.

    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 H7493893612270 12916056

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention