BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 2874014 · Received December 14, 2012

    Report

    Report Number
    0002954917-2012-00137
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    July 12, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: FOR ANTICIPATED PROCEDURAL COMPLICATION. 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 IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Additional Manufacturer Narrative · 1

    COMPLAINT SOURCE - LITERATURE: MONIKA KILLER-OBERPFALZER ET AL. J NEURORADIOLOGY (AUSTRIA) E-PUB. JULY 2012. PMA/510(K)# - K082034; K090085 AND K081305. THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEURORADIOLOGY THAT (B)(4) PATIENTS UNDERWENT MECHANICAL THROMBECTOMY WITH THE RETRIEVAL DEVICES TO TREAT CEREBRAL ARTERIES OCCLUSIONS. (B)(4) REPORTS OF SEVERE INTRACEREBRAL HEMORRHAGE (ICH), (B)(4) HAD A SLIGHT HEMORRHAGIC TRANSFORMATION OF THE CEREBRAL INFARCTION AND (B)(4) CASES THAT RESULTED IN DECOMPRESSIVE SURGERIES BECAUSE OF THE RETRIEVER'S FAILURE AND SPACE OCCUPYING INFARCTION. THE PATIENTS UNDERWENT TREATMENT BETWEEN 2006 AND 2009, IT WAS NOT POSSIBLE TO IDENTIFY THE NUMBER OF PATIENTS INVOLVED IN THE REPORTED ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED IN AN ARTICLE IN NEURORADIOLOGY THAT 60 PATIENTS UNDERWENT MECHANICAL THROMBECTOMY WITH THE RETRIEVAL DEVICES TO TREAT CEREBRAL ARTERIES OCCLUSIONS. A 17 REPORTS OF SEVERE INTRACEREBRAL HEMORRHAGE (ICH), 16 HAD A SLIGHT HEMORRHAGIC TRANSFORMATION OF THE CEREBRAL INFARCTION AND 10 CASES THAT RESULTED IN DECOMPRESSIVE SURGERIES BECAUSE OF THE RETRIEVER'S FAILURE AND SPACE OCCUPYING INFARCTION. THE PATIENTS UNDERWENT TREATMENT BETWEEN 2006 AND 2009, IT WAS NOT POSSIBLE TO IDENTIFY THE NUMBER OF PATIENTS INVOLVED IN THE REPORTED ADVERSE EVENTS.

    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 Other| R