BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAVERICK2 BALLOON CATHETER

    MDR report key: 3089848 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-02838
    Event Type
    Death
    Date Received
    May 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 62 +/- 14 YEARS. DEATH DATE/EVENT DATE: BETWEEN AUGUST 2003 AND SEPTEMBER 2009. JOURNAL ARTICLE: THANH N. NGUYEN, MD; OSAMA O. ZAIDAT, MD; RISHI GUPTA, MD; RAUL G. NOGUEIRA, MD; NAUMAN TARIQ, MD; JUNAID S. KALIA, MD; ALEXANDER M. NORBASH, MD; ADNAN I. QURESHI, MD (2010). BALLOON ANGIOPLASTY FOR INTRACRANIAL ATHEROSCLEROTIC DISEASE PERIPROCEDURAL RISKS AND SHORT-TERM OUTCOMES IN A MULTICENTER STUDY. 2010 AMERICAN HEART ASSOCIATION, INC. PGS. 107-111. 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

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT POST PROCEDURAL COMPLICATIONS OF ISCHEMIC STROKE AND SUBSEQUENT DEATH WERE OBSERVED. THE PATIENT WAS DIAGNOSED WITH INTRACRANIAL ATHEROSCLEROTIC DISEASE (ICAD) AND WAS SELECTED FOR PRIMARY ANGIOPLASTY TREATMENT. THE PATIENT HAD MEASURED BASELINE STENOSIS OF >/= 50% USING WARFARIN-ASPIRIN SYMPTOMATIC INTRACRANIAL DISEASE (WASID) CRITERIA. THE PATIENT WAS TREATED USING FEMORAL ACCESS AND PLACEMENT OF A 6-FR OR 7-FR GUIDE CATHETER IN THE CERVICAL CAROTID OR VERTEBRAL ARTERY. INTRAVENOUS HEPARIN WAS GIVEN AFTER GROIN PUNCTURE WITH THE GOAL TO MAINTAIN ACTIVATED CLOTTING TIME >250 SECONDS. AFTER DIAGNOSTIC ANGIOGRAPHY, A MAVERICK BALLOON CATHETER WAS ADVANCED ACROSS THE LESION OVER A 0.014-INCH MICROWIRE EITHER WITH DIRECT ACCESS OR AFTER MICROCATHETER EXCHANGE. THE BALLOON WAS INFLATED SLOWLY UNDER FLUOROSCOPIC ROADMAP GUIDANCE OVER SEVERAL SECONDS TO THE NOMINAL INFLATION PRESSURES AND KEPT INFLATED FOR APPROXIMATELY 15 TO 30 SECONDS AND THEN DEFLATED. THE PATIENT WAS DISCHARGED ON ANTIPLATELET THERAPY UNLESS WARFARIN WAS REQUIRED FOR A HISTORY OF ATRIAL FIBRILLATION. IN ONE CASE, A PATIENT WITH 90% BASILAR ARTERY STENOSIS DEVELOPED BILATERAL POSTERIOR FOSSA ISCHEMIC STROKE AND DIED WITHIN 6 HOURS AFTER ANGIOPLASTY WITH THE MAVERICK BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193030 MAVERICK2 BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK228

    Patients

    Seq Age Sex Outcome Treatment
    1 Death