BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 3790984 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-00096
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    DXE
    PMA / PMN Number
    NA
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS "REVIVE THROMBECTOMY DEVICE, SELF-EXPANDING" PATIENT HAS SAH (SUBARACHNOID HEMORRHAGE) POST INDEX PROCEDURE. ON (B)(6) 2014, THE INDEX PROCEDURE WAS PERFORMED WITH PASSAGE OF THE REV-01 DEVICE 3(THREE) TIMES; HOWEVER, POST-PROCEDURAL ANGIOGRAM SHOWED INCOMPLETE BLOOD FLOW OF TICI SCORE 0. A SOLITAIRE DEVICE WAS THEN USED FOR 3 PASSES WITH RESULTING TICI 2B RECANALIZATION. SAH WAS NOTED BY BRAIN CT THE SAME DAY AS THE PROCEDURE, NIHSS SCORE WAS RECORDED AS 8. (B)(6) 2014, THERE WAS NO COGNITIVE DYSFUNCTION REMAINING, CONVERSATION WAS ESTABLISHED PROPERLY. IT WAS NOTED THAT THERE WAS LESS PERMEABILITY ON BREATH CT, INCREASE ON CRP AND FEVER, PROBABLY DUE TO COMPLICATION OF ASPIRATION PNEUMONIA AT ONSET OF STROKE. ON (B)(6) 2014, NIHSS SCORE WAS 7. ON (B)(6) 2014 THERE WAS A DECREASED LEVEL OF CONSCIOUSNESS WITH GRADUALLY PROLONGED EXPIRATION. AT 19:00 THE BLOOD GAS RESULTS WERE; PH 7.269, PCO2 113, PO2, 173, HCO3 50.1. IT WAS SUSPECTED THAT THIS WAS RESPIRATORY DEPRESSION ASSOCIATED WITH SYMPTOMATIC EPILEPSY SEIZURE. ADMINISTRATION OF HORIZON AND FOSTOIN WERE DONE. TRACHEAL CANNULATION ALONG WITH ARTIFICIAL RESPIRATOR WERE PLACED. FEVER OVER 39 DEGREES, AND INCREASED AMOUNT OF SPUTUM WERE OBSERVED. ON (B)(6) 2014, ELECTROENCEPHALOGRAPHY WAS DONE. THERE IS NO REPORT OF THOSE RESULTS AT THIS TIME. ON (B)(6) 2014, TRACHEAL CANNULATION WAS WITHDRAWN AS THE RESPIRATORY CONDITION IMPROVED. LEVEL OF CONSCIOUSNESS IMPROVED BUT THERE WAS STILL UNSTABLE CIRCULATION DYNAMICS WITH INCREASED EFFORT OF RESPIRATION. DIAGNOSIS MADE BY RESPIRATORY PHYSICIAN; THE RETENTION OF CO2 WAS CAUSED BY WORSENING OF ASPIRATION PNEUMONIA, COMBINED RESPIRATORY DISTURBANCE AND THORACIC DEFORMITY STATUS POST CARDIAC SURGERY IN THE PAST. BLOOD GASES WERE NOTED TO BE; PH7.353, PCO2 59.6, PO2 59.9, HCO3 32.3 MECHANICAL VENTILATION WAS DONE WITH MASK-TO-FACE SYSTEM. A PROWLER SELECT PLUS (B)(4) WAS USED TO DELIVER THE RE-VIVE DEVICE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGHOUT THE PROCEDURE. THE TARGET SITE WAS RIGHT M1, DESCRIBED AS MODERATELY CURVED. THERE WAS NO DAMAGE NOTED TO THE VESSEL AFTER USE OF THE RE-VIVE. THERE WERE NO DAMAGES NOTED TO THE DEVICE AFTER IT WAS REMOVED FROM THE PATIENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, TARGET SITE AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS "REVIVE THROMBECTOMY DEVICE, SELF-EXPANDING" PATIENT HAS SAH (SUBARACHNOID HEMORRHAGE) POST INDEX PROCEDURE. (B)(6) 2014, THE INDEX PROCEDURE WAS PERFORMED WITH PASSAGE OF THE REV-01 DEVICE 3 (THREE) TIMES; HOWEVER, POST-PROCEDURAL ANGIOGRAM SHOWED INCOMPLETE BLOOD FLOW OF TICI SCORE 0. A SOLITAIRE DEVICE WAS THEN USED FOR 3 PASSES WITH RESULTING TICI 2B RECANALIZATION. SAH WAS NOTED BY BRAIN CT THE SAME DAY AS THE PROCEDURE, NIHSS SCORE WAS RECORDED AS 8. (B)(6) 2014, THERE WAS NO COGNITIVE DYSFUNCTION REMAINING, CONVERSATION WAS ESTABLISHED PROPERLY. IT WAS NOTED THAT THERE WAS LESS PERMEABILITY ON BREATH CT, INCREASE ON CRP AND FEVER, PROBABLY DUE TO COMPLICATION OF ASPIRATION PNEUMONIA AT ONSET OF STROKE. (B)(6) 2014, NIHSS SCORE WAS 7. (B)(6) 2014 THERE WAS A DECREASED LEVEL OF CONSCIOUSNESS WITH GRADUALLY PROLONGED EXPIRATION. AT 19:00 THE BLOOD GAS RESULTS WERE; PH 7.269, PCO2 113, PO2, 173, HCO3 50.1. IT WAS SUSPECTED THAT THIS WAS RESPIRATORY DEPRESSION ASSOCIATED WITH SYMPTOMATIC EPILEPSY SEIZURE. ADMINISTRATION OF HORIZON AND FOSTOIN WERE DONE. TRACHEAL CANNULATION ALONG WITH ARTIFICIAL RESPIRATOR WERE PLACED. FEVER OVER 39 DEGREES, AND INCREASED AMOUNT OF SPUTUM WERE OBSERVED. (B)(6) 2014, ELECTROENCEPHALOGRAPHY WAS DONE. THERE IS NO REPORT OF THOSE RESULTS AT THIS TIME. (B)(6) 2014, TRACHEAL CANNULATION WAS WITHDRAWN AS THE RESPIRATORY CONDITION IMPROVED. LEVEL OF CONSCIOUSNESS IMPROVED BUT THERE WAS STILL UNSTABLE CIRCULATION DYNAMICS WITH INCREASED EFFORT OF RESPIRATION. DIAGNOSIS MADE BY RESPIRATORY PHYSICIAN; THE RETENTION OF CO2 WAS CAUSED BY WORSENING OF ASPIRATION PNEUMONIA, COMBINED RESPIRATORY DISTURBANCE AND THORACIC DEFORMITY STATUS POST CARDIAC SURGERY IN THE PAST. BLOOD GASES WERE NOTED TO BE; PH7.353, PCO2 59.6, PO2 59.9, HCO3 32.3 MECHANICAL VENTILATION WAS DONE WITH MASK-TO-FACE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266667 REVIVE - THROMBECTOMY DEVICE MICRUS THROMBECTOMY DXE MICRUS ENDOVASCULAR, LLC T10000

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening UNK MICROCATHETER