BEUDAMED
    FDA Adverse Event Death Summary report: N

    TREVO XP PROVUE RETRIEVER 4X20

    MDR report key: 4097264 · Received September 17, 2014

    Report

    Report Number
    0002954917-2014-00031
    Event Type
    Death
    Date Received
    September 17, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K132641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS. 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. DEATH, HEMATOMA AND PATIENT COMPLICATIONS ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR PASSES WITH THE SUBJECT RETRIEVAL DEVICE WERE SUCCESSFULLY PERFORMED TO TREAT THE RIGHT A2 ANTERIOR CEREBRAL ARTERY (ACA) AND M2 MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B AFTER TREATMENT. HOWEVER, POST PROCEDURE A NEW ONSET OF ATRIAL FIBRILLATION WAS NOTED. MEDICAL MANAGEMENT (THE EXACT MEDICATION AND DOSAGE UNKNOWN) WAS ADMINISTERED. TWO DAYS POST PROCEDURE THE PATIENT¿S NEUROLOGICAL STATUS DETERIORATED DUE TO PROGRESSION OF THE INDEX STROKE, WHICH LED TO THE PATIENT¿S DEATH. THE PRIMARY CAUSE OF DEATH WAS A LARGE ISCHEMIC STROKE. THE PHYSICIAN STATED THAT THE PATIENT¿S DEATH WAS UNRELATED TO THE SUBJECT DEVICE; HOWEVER, IT IS UNKNOWN IF THE PROCEDURE CAUSED OR CONTRIBUTED TO THE DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR PASSES WITH THE SUBJECT RETRIEVAL DEVICE WERE SUCCESSFULLY PERFORMED TO TREAT THE RIGHT A2 ANTERIOR CEREBRAL ARTERY (ACA) AND M2 MIDDLE CEREBRAL ARTERY (MCA) OCCLUSION. THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2B AFTER TREATMENT. HOWEVER, POST PROCEDURE A NEW ONSET OF ATRIAL FIBRILLATION WAS NOTED. MEDICAL MANAGEMENT (THE EXACT MEDICATION AND DOSAGE UNKNOWN) WAS ADMINISTERED. TWO DAYS POST PROCEDURE THE PATIENT¿S NEUROLOGICAL STATUS DETERIORATED DUE TO PROGRESSION OF THE INDEX STROKE, WHICH LED TO THE PATIENT¿S DEATH. THE PRIMARY CAUSE OF DEATH WAS A LARGE ISCHEMIC STROKE. THE PHYSICIAN STATED THAT THE PATIENT¿S DEATH WAS UNRELATED TO THE SUBJECT DEVICE; HOWEVER, IT IS UNKNOWN IF THE PROCEDURE CAUSED OR CONTRIBUTED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576605 TREVO XP PROVUE RETRIEVER 4X20 CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL 37121

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death