BEUDAMED
    FDA Adverse Event Death Summary report: N

    V 2.0 SOFT EXT PTFE

    MDR report key: 3022091 · Received March 26, 2013

    Report

    Report Number
    0002954917-2013-00039
    Event Type
    Death
    Date Received
    March 26, 2013
    Date of Event
    July 13, 2012
    Report Date
    March 8, 2013
    Manufacturer
    CONCENTRIC MEDICAL
    Product Code
    NRY
    PMA / PMN Number
    K082034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: DEVICE CODE - CORRECTED.

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN DISPOSED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED; THEREFORE, PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, PATIENT COMPLICATIONS AND DEATH ARE NOTED AS POTENTIAL COMPLICATIONS ASSOCIATED WITH SUCH PROCEDURES IN THE DIRECTION FOR USE (DFU). THEREFORE, A ROOT CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS HAS BEEN ASSIGNED TO THIS EVENT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE A RETRIEVER WAS USED FOR A LEFT MIDDLE CEREBRAL ARTERY (L-MCA) OCCLUSION. ONE PASS WAS MADE WITH THIS RETRIEVER. AFTER DEPLOYMENT THE RETRIEVER BECAME STUCK AND THE PHYSICIAN COULD NOT WITHDRAW THE RETRIEVER FROM THE VESSEL. THE RETRIEVER WAS WITHDRAWN WITH FORCE AND THE PATIENT EXPEREINCED A TEMPORAL DECLINE IN BLOOD PRESSURE. THE PATIENT EXPIRED TWO DAYS POST PROCEDURE DUE TO CEREBRAL HERNIA. THE PHYSICIAN BELIEVES THAT THAT THE PATIENT'S OUTCOME IS A NATURAL COURSE OF CEREBRAL INFARCTION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE A RETRIEVER WAS USED FOR A LEFT MIDDLE CEREBRAL ARTERY (L-MCA) OCCLUSION. ONE PASS WAS MADE WITH THIS RETRIEVER. AFTER DEPLOYMENT THE RETRIEVER BECAME STUCK AND THE PHYSICIAN COULD NOT WITHDRAW THE RETRIEVER FROM THE VESSEL. THE RETRIEVER WAS WITHDRAWN WITH FORCE AND THE PATIENT EXPERIENCED A TEMPORAL DECLINE IN BLOOD PRESSURE. THE PATIENT EXPIRED TWO DAYS POST PROCEDURE DUE TO CEREBRAL HERNIA. THE PHYSICIAN BELIEVES THAT THE PATIENT'S OUTCOME IS A NATURAL COURSE OF CEREBRAL INFARCTION.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A RETRIEVER WAS USED FOR A LEFT MIDDLE CEREBRAL ARTERY (L-MCA) OCCLUSION. ONE PASS WAS MADE WITH THIS RETRIEVER. AFTER DEPLOYMENT, THE RETRIEVER BECAME STUCK AND THE PHYSICIAN COULD NOT WITHDRAW THE RETRIEVER FROM THE VESSEL. THE RETRIEVER WAS WITHDRAWN WITH FORCE AND THE PATIENT EXPERIENCED A TEMPORAL DECLINE IN BLOOD PRESSURE. THE PATIENT EXPIRED TWO DAYS POST PROCEDURE DUE TO CEREBRAL HERNIA. THE PHYSICIAN BELIEVES THAT THE PATIENT'S OUTCOME IS A NATURAL COURSE OF CEREBRAL INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124547 V 2.0 SOFT EXT PTFE CATHETER, THROMBUS RETRIEVER NRY CONCENTRIC MEDICAL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death