BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 2894092 · Received January 3, 2013

    Report

    Report Number
    2134265-2012-08277
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 4, 2010
    Report Date
    December 6, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    (B)(4). SAME CASE AS: 2134265-2012-08278. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND MYOCARDIAL INFARCTION. THE 98% IN-STENT RESTENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD). PREDILATION WAS PERFORMED WITH A 2MM APEX BALLOON. THE LESION WAS TREATED WITH THE PLACEMENT 2 (2.25X20MM AND 2.25X12MM) TAXUS LIBERTE STENTS. POST DILATION WAS PERFORMED WITH THE STENT BALLOON. DURING THE PROCEDURE, THE PATIENT WAS GIVEN INTRACORONARY NITROGLYCERIN TO RELIEVE THE CORONARY SPASM. THE PATIENT WAS ALSO GIVEN INTRAVENOUS ANGIOMAX DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED ON ASPIRIN, PLAVIX AND PLETAL. IN (B)(6) 2010, THE PATIENT PRESENTED WITH CHEST PAIN AND HAS HAD NON ST-ELEVATION MYOCARDIAL INFARCTION. MULTIPLE ANGIOGRAM OF THE LEFT INTERNAL MAMMARY ARTERY (LIMA) GRAFT TO LAD WAS PERFORMED. THE DISTAL LAD WAS 99% STENOSED. THE DISTAL LAD WAS WIRED WITH A NON-BSC WIRE. THE WIRE WAS REMOVED AND ANOTHER NON-BSC WIRE WAS ADVANCED TO THE DISTAL LAD WITH THE USE OF A 2.5X12MM APEX BALLOON. THE BALLOON WAS INFLATED AT 6 ATM FOR 180 SECONDS. THE DISTAL LAD WAS STENTED USING A 2.25X8MM TAXUS ATOM STENT. POST DILATION WAS PERFORMED WITH A 2.5X12MM AND A 2.5X15MM QUANTUM APEX BALLOON. THE PHYSICIAN DEPLOYED A 2.25X12MM TAXUS ATOM STENT AT 12 ATM IN THE LESION. POST DILATION WAS PERFORMED WITH A 2.5X15MM APEX BALLOON. GOOD ANGIOGRAM OF THE LIMA TO LAD WAS OBTAINED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3394 TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE UNK433

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention