BEUDAMED
    FDA Adverse Event Death Summary report: N

    TREVO XP PROVUE RETRIEVER 3X20

    MDR report key: 6039049 · Received October 19, 2016

    Report

    Report Number
    0002954917-2016-00150
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    May 1, 2016
    Report Date
    December 20, 2016
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K132641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. ALL PATIENTS WERE TREATED BETWEEN 2014 AND 2016. THIS IS 2 OF 5 REPORTS FOR THIS ARTICLE.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. HOWEVER, EMBOLI, STROKE, EDEMA, HERNIA AND DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    THE ARTICLE PRESENTED RETROSPECTIVE EVALUATION OF TWO YEAR (2014-2016) EXPERIENCE FOR ONE-SINGLE SITE OF THE SAFETY AND EFFICACY OF THE RETRIEVER DEVICES FOR LARGE VESSEL OCCLUSIONS (LVOS) IN ACUTE ISCHEMIC STROKE (AIS). THIRTY-FIVE PATIENTS WITH A MEAN NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) SCORE OF 18 WERE INCLUDED. THE SUBJECT RETRIEVER DEVICE WAS USED IN 38 BRANCHES OF THE ANTERIOR AND POSTERIOR CIRCULATIONS. THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B/3 BLOOD FLOW WAS RESTORED AFTER ONE SINGLE PASS IN 20/38 (52.6%) AND AFTER TWO OR THREE PASSES IN 11 VESSELS. A SECOND CASE OF CLOT MIGRATION WAS SEEN DURING A VERTEBRAL ARTERY (VA) THROMBECTOMY PROCEDURE USING THE SUBJECT DEVICE. THE CLOT MIGRATED TOO DISTALLY INTO THE SUPERIOR CEREBELLAR ARTERY (SCA) AND COULD NOT BE RETRIEVED, THUS LEADING TO CEREBELLAR INFARCTS ON FOLLOW-UP IMAGING RELATED TO THE SCA OCCLUSION. ADDITIONAL INFARCTS IN THE TREATED VASCULAR TERRITORY WERE NOTED. THE PATIENT LATER DIED OWING TO SIGNIFICANT INFARCTION IN THE POSTERIOR CIRCULATION AND DEVELOPMENT OF SIGNIFICANT EDEMA LEADING TO TONSILLAR HERNIATION. NO FURTHER DETAILS PROVIDED.

    Description of Event or Problem · 1

    THE ARTICLE PRESENTED RETROSPECTIVE EVALUATION OF TWO YEAR (2014-2016) EXPERIENCE FOR ONE-SINGLE SITE OF THE SAFETY AND EFFICACY OF THE RETRIEVER DEVICES FOR LARGE VESSEL OCCLUSIONS (LVOS) IN ACUTE ISCHEMIC STROKE (AIS). THIRTY-FIVE PATIENTS WITH A MEAN NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) SCORE OF 18 WERE INCLUDED. THE SUBJECT RETRIEVER DEVICE WAS USED IN 38 BRANCHES OF THE ANTERIOR AND POSTERIOR CIRCULATIONS. THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B/3 BLOOD FLOW WAS RESTORED AFTER ONE SINGLE PASS IN 20/38 (52.6%) AND AFTER TWO OR THREE PASSES IN 11 VESSELS. A SECOND CASE OF CLOT MIGRATION WAS SEEN DURING A VERTEBRAL ARTERY (VA) THROMBECTOMY PROCEDURE USING THE SUBJECT DEVICE. THE CLOT MIGRATED TOO DISTALLY INTO THE SUPERIOR CEREBELLAR ARTERY (SCA) AND COULD NOT BE RETRIEVED, THUS LEADING TO CEREBELLAR INFARCTS ON FOLLOW-UP IMAGING RELATED TO THE SCA OCCLUSION. ADDITIONAL INFARCTS IN THE TREATED VASCULAR TERRITORY WERE NOTED. THE PATIENT LATER DIED OWING TO SIGNIFICANT INFARCTION IN THE POSTERIOR CIRCULATION AND DEVELOPMENT OF SIGNIFICANT EDEMA LEADING TO TONSILLAR HERNIATION. NO FURTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692387 TREVO XP PROVUE RETRIEVER 3X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O