BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    MDR report key: 1874191 · Received October 19, 2010

    Report

    Report Number
    2134265-2010-04706
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P060008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER. THE COMPLAINANT 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 DURING A STENTING TREATMENT PROCEDURE, VESSEL SPASM, CHEST PAIN AND CARDIAC ARREST OCCURRED. THE PATIENT PRESENTED WITH UNSTABLE ANGINA. ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. THE LESION WAS LOCATED IN A CRITICALLY STENOSED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS IMAGED USING IVUS AND THE PHYSICIAN ELECTED TO TREAT THE LESION. A 2.75X38MM TAXUS LIBERTE STENT WAS ADVANCED TO THE LESION. WHILE THE STENT WAS ON THE GUIDE WIRE, BUT NOT YET TO THE LESION, A VESSEL SPASM OCCURRED. ACUTE CLOSURE WAS SEEN OF BOTH THE LAD AND LEFT CIRCUMFLEX ARTERIES. THE PATIENT THEN REPORTED CHEST PAIN, BECAME UNRESPONSIVE AND WENT INTO CARDIAC ARREST. 3MCG ADENOSINE AND 100MCG NITROGLYCERIN WERE GIVEN IC AND THE DOPAMINE DOSE WAS INCREASED. CPR WAS STARTED AND THE PATIENT WAS INTUBATED. THE PATIENT MAINTAINED A PULSE AND EPINEPHRINE AND ATROPINE WERE GIVEN AND THE PATIENT WAS BAGGED TO ASSIST WITH RESPIRATIONS. AT THIS POINT THE PATIENT BECAME RESTLESS AND WAS NOT RESPONDING TO COMMANDS. THE PATIENT WAS ANESTHETIZED AND PLACED ON A VENTILATOR. AFTER CONSULTATION, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE A CORONARY ARTERY BYPASS GRAFT WAS PERFORMED. NO FURTHER PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS LISTED AS STABLE.

    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 H7493893638270

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention 190CM BMW GUIDE WIRE| 6FR 100CM FL4 EXPO GUIDE CATHETER| ATLANTIS SRPRO IMAGING CATHETER