BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1873742 · Received October 19, 2010

    Report

    Report Number
    2134265-2010-04658
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    June 16, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENTS DATE OF BIRTH (B)(6).

    Additional Manufacturer Narrative · 1

    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

    SAME CASE AS 2134265-2010-05581 AND 2134265-2010-05582. IT WAS FURTHER REPORTED THAT THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS A 3.00MM, 50.0MM LONG 90% STENOSED. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION, AND SUCCESSFULLY IMPLANTING THREE (3.00X28MM, 3.00X12MM AND A 2.50X12MM) TAXUS LIBERTE STENTS WITHOUT GAP, AND POST-DILATATION. RESIDUAL STENOSIS BECAME VISUALLY 0% AND TIMI-3 FLOW HAD BEEN KEPT SINCE PRE-INDEX PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS TWO DAYS LATER ON ASPIRIN AND CLOPIDOGREL BISULFATE. 264 DAYS POST-INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA. PCI WAS PERFORMED. THE TARGET LESION WAS VISUALLY 90% STENOSED. THE PHYSICIAN TREATED THE LESION WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A NON BSC STENT. RESIDUAL STENOSIS BECAME 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Description of Event or Problem · 1

    SAME CASE AS 2134265-2010-05581 AND 2134265-2010-05582. IT WAS FURTHER REPORTED THAT THE LESION BEING TREATED IN THE INDEX PROCEDURE WAS A 3.00MM, 50.0MM LONG 90% STENOSED. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION, AND SUCCESSFULLY IMPLANTING THREE (3.00X28MM, 3.00X12MM AND A 2.50X12MM) TAXUS LIBERTE STENTS WITHOUT GAP, AND POST-DILATATION. RESIDUAL STENOSIS BECAME VISUALLY 0% AND TIMI-3 FLOW HAD BEEN KEPT SINCE PRE-INDEX PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT COMPLICATIONS TWO DAYS LATER ON ASPIRIN AND CLOPIDOGREL BISULFATE. AT 264 DAYS POST-INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA. PCI WAS PERFORMED. THE TARGET LESION WAS VISUALLY 90% STENOSED. THE PHYSICIAN TREATED THE LESION WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A NON BSC STENT. RESIDUAL STENOSIS BECAME 0%. THE PATIENT WAS DISCHARGED THE NEXT DAY.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY TREATMENT PROCEDURE THE PATIENT EXPERIENCED ANGINA. THE LESION BEING TREATED WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. THE PHYSICIAN IMPLANTED A TAXUS LIBERTE STENT OF UNKNOWN SIZE IN THE LESION. IN (B)(6) 2010, THE PATIENT DEVELOPED ANGINA PECTORIS. NINE-MONTH FOLLOW-UP ANGIOGRAPHY WAS PERFORMED. RESULTS REVEALED THE TARGET VESSEL DIAMETER WAS 3.00MM, 35MM LONG WITH 90% STENOSIS. THE PHYSICIAN PERFORMED A TVR USING AN UNKNOWN BALLOON CATHETER AND UNKNOWN SIZE NON BSC STENT WITH RESIDUAL STENOSIS BEING 0%. THE PATIENT WAS DISCHARGED 2 DAYS LATER WITH THE PATIENTS SYMPTOMS IMPROVED. THERE WAS NO ANGINAL SYMPTOMS REPORTED AT THE 1 YEAR FOLLOW-UP.

    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 - GALWAY H7493893628300

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 3.00X12MM TAXUS LIBERTE STENT| 2.50X12MM TAXUS LIBERTE STENT