BEUDAMED
    FDA Adverse Event Death Summary report: N

    V 2.5 FIRM EXT

    MDR report key: 2863350 · Received December 10, 2012

    Report

    Report Number
    0002954917-2012-00129
    Event Type
    Death
    Date Received
    December 10, 2012
    Date of Event
    June 7, 2012
    Report Date
    November 12, 2012
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K081305
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. VESSEL DISSECTION, 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED THREE PASSES WITH THE RETRIEVAL DEVICES TO TREAT A BASILAR ARTERY (BA) AND A LEFT POSTERIOR CEREBRAL ARTERY (L-PCA) OCCLUSION. HOWEVER, THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 1 AFTER PASSES. THE PHYSICIAN MADE ONE MORE PASS AND AS THE SECOND RETRIEVER (THE SUBJECT DEVICE) WAS DEPLOYED IN THE L-PCA, THE PATIENT SUFFERED A SUDDEN RESPIRATORY ARREST AND IMPAIRED CONSCIOUSNESS. A HEMORRHAGE AT THE L-PCA WAS CONFIRMED DURING THE PROCEDURE. HEPARIN WAS REVERSED AND THE PATIENT WAS INTUBATED. TWO DAYS POST PROCEDURE THE PATIENT DIED. THE PHYSICIAN STATED THAT THE HEMORRHAGE AT L-PCA WAS DUE TO A VESSEL DISSECTION CAUSED BY THE USE OF THE SECOND RETRIEVER (THE SUBJECT DEVICE) AND THE PATIENT OUTCOME IS RELATED TO THE HEMORRHAGE AT L-PCA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY PERFORMED THREE PASSES WITH THE RETRIEVAL DEVICES TO TREAT A BASILAR ARTERY (BA) AND A LEFT POSTERIOR CEREBRAL ARTERY (L-PCA) OCCLUSION. HOWEVER, THE PATIENT HAD A THROMBOLYSIS IN CEREBRAL ISCHEMIA (TICI) SCORE OF 1 AFTER PASSES. THE PHYSICIAN MADE ONE MORE PASS AND AS THE SECOND RETRIEVER (THE SUBJECT DEVICE) WAS DEPLOYED IN THE L-PCA, THE PATIENT SUFFERED A SUDDEN RESPIRATORY ARREST AND IMPAIRED CONSCIOUSNESS. A HEMORRHAGE AT THE L-PCA WAS CONFIRMED DURING THE PROCEDURE. HEPARIN WAS REVERSED AND THE PATIENT WAS INTUBATED. TWO DAYS POST PROCEDURE THE PATIENT DIED. THE PHYSICIAN STATED THAT THE HEMORRHAGE AT L-PCA WAS DUE TO A VESSEL DISSECTION CAUSED BY THE USE OF THE SECOND RETRIEVER (THE SUBJECT DEVICE) AND THE PATIENT OUTCOME IS RELATED TO THE HEMORRHAGE AT L-PCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V 2.5 FIRM EXT CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death MERCI MICROCATHETER 18L (CONCENTRIC)