BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 2873003 · Received December 13, 2012

    Report

    Report Number
    0002954917-2012-00133
    Event Type
    Death
    Date Received
    December 13, 2012
    Date of Event
    October 9, 2011
    Report Date
    December 8, 2012
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K)# - K120961/ K122478. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CONCLUSION: FOR ANTICIPATED PROCEDURAL AND PATIENT COMPLICATIONS. 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. HEMORRHAGE AND DEATH 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 AND PATIENT COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROIMAGING THAT THE PATIENT UNDERWENT MECHANICAL THROMBECTOMY USING THE SUBJECT RETRIEVAL DEVICE TO TREAT A MIDDLE CEREBRAL ARTERY OCCLUSION. THE PATIENT SUFFERED AN INTRACEREBRAL HEMORRHAGE ON THE THIRD DAY POST-PROCEDURE AND DIED. THE PATIENT UNDERWENT THE PROCEDURE BETWEEN (B)(6) 2010 AND (B)(6)2011. THE EXACT DATE OF THE PROCEDURE AND DEATH ARE UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEUROIMAGING THAT THE PATIENT UNDERWENT MECHANICAL THROMBECTOMY USING THE SUBJECT RETRIEVAL DEVICE TO TREAT A MIDDLE CEREBRAL ARTERY OCCLUSION. THE PATIENT SUFFERED AN INTRACEREBRAL HEMORRHAGE ON THE THIRD DAY POST-PROCEDURE AND DIED. THE PATIENT UNDERWENT THE PROCEDURE BETWEEN (B)(6) 2010 AND (B)(6) 2011. THE EXACT DATE OF THE PROCEDURE AND DEATH ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN_NEUROVASCULAR_PRODUCT CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death