BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROTÉGÉ ®RX SELF EXPANDING NITINOL STENT

    MDR report key: 2532182 · Received April 12, 2012

    Report

    Report Number
    2183870-2012-00070
    Event Type
    Death
    Date Received
    April 12, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 21, 2012
    Manufacturer
    EV3 INC.
    Product Code
    NIM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. STENT WAS IMPLANTED.

    Description of Event or Problem · 1

    THIS PROCEDURE IS PART OF (B)(4): THE PATIENT WAS UNDERGOING RICA CAROTID INTERVENTION, AND SUFFERED A TIA DURING THE PROCEDURE. THE SPIDERFX WAS SUCCESSFULLY PLACED WITHOUT INCIDENT, THE LESION WAS THEN PRE-DILATED. IMMEDIATELY AFTER PRE-DILATION, THE PATIENT WAS UNABLE TO SPEAK AND BECAME WEAK ON HER RIGHT SIDE. PHYSICIAN PROCEEDED WITH PROTÉGÉ RX STENT PLACEMENT AND POST-DIL. THE SPIDERFX DWELL TIME WAS <10 MIN, AND THERE WAS NO DEBRIS IN THE FILTER UPON RETRIEVAL. THE PATIENT'S SYMPTOMS WERE IMPROVED POST PROCEDURE, BUT NOT BACK TO NEURO BASELINE. THE PATIENT WAS THEN SEEN BY NEUROLOGY AND INTERVENTIONAL RADIOLOGY TEAMS AND TAKEN FOR A CAT SCAN AND TO IR LAB TO ATTEMPT INTERVENTION TO TREAT TIA SYMPTOMS. THE PATIENT THEN SUFFERED INTRACRANIAL BLEED AND REMAINS IN CRITICAL CONDITION. THE PATIENT EXPIRED ON (B)(6) 2012. PLEASE REFERENCE MDR 2183870-2012-00069 FOR THE SPIDERFX USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®RX SELF EXPANDING NITINOL STENT STENT, CAROTID NIM EV3 INC. SECX-10-7-30-135 9556722

    Patients

    Seq Age Sex Outcome Treatment
    1 Death SPIDERFX