BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS? LIBERTÉ?

    MDR report key: 4143492 · Received October 6, 2014

    Report

    Report Number
    2134265-2014-05994
    Event Type
    Injury
    Date Received
    October 6, 2014
    Date of Event
    August 20, 2014
    Report Date
    September 9, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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

    IT WAS REPORTED THAT STENT THROMBOSIS AND CHEST PAIN OCCURRED. THE PATIENT PRESENTED WITH ACUTE ANTERIOR WALL MYOCARDIAL INFARCTION (AWMI). VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER THE LEFT MAIN CORONARY ARTERY WAS CANNULATED WITH A 6FR NON BSC GUIDE CATHETER AND A NON BSC GUIDEWIRE CROSSED THE LESION, THROMBOSUCTION WAS PERFORMED WITH A NON BSC ASPIRATION CATHETER. A 12 X 3.00MM TAXUS¿ LIBERTÉ¿ DRUG ELUTING STENT WAS IMPLANTED DIRECTLY ACROSS THE LAD AT 14 ATMOSPHERES FOR 30 SECONDS. POST DILATATION WAS DONE USING A 3X9 MAVERICK BALLOON CATHETER AT 16 ATMOSPHERES FOR 30 SECONDS. THE END RESULT WAS GOOD. 5 DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF SEVERE CHEST PAIN AND WAS DIAGNOSED WITH ACUTE EXTENSIVE AWMI. CORONARY ANGIOGRAPHY (CAG) REVEALED 100% OCCLUSION WITH IN-STENT THROMBUS OF THE TAXUS¿ LIBERTÉ¿ STENT. THROMBOSUCTION WAS PERFORMED WITH A 6FR NON BSC ASPIRATION CATHETER AND PREDILATION USING A 2X12 MAVERICK BALLOON CATHETER. A 2.75X23 NON BSC STENT WAS DEPLOYED ACROSS THE LAD. INTRA CORONARY INJECTION OF NITROGLYCERIN (NTG) & SODIUM NITROPRUSSIDE WAS ADMINISTERED AND THE END RESULT WAS GOOD. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622931 TAXUS? LIBERTÉ? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - GALWAY H7493894012300

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R