BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2981459 · Received February 27, 2013

    Report

    Report Number
    2029214-2013-00180
    Event Type
    Death
    Date Received
    February 27, 2013
    Date of Event
    January 31, 2013
    Report Date
    January 31, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT ICA (INTERNAL CAROTID ARTERY) P-COMM (POSTERIOR COMMUNICATING ARTERY) SIDEWALL ANEURYSM MEASURING APPROXIMATELY 10 MM TO 12 MM. DURING PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PIPELINE DID NOT RELEASE FROM THE CAPTURE COIL. THE MARKSMAN CATHETER WAS MANIPULATED IN ORDER TO RELEASE THE PIPELINE FROM THE CAPTURE COIL WITHOUT SUCCESS. A DECISION WAS MADE TO RETRIEVE THE PIPELINE; HOWEVER, THE REST OF THE PIPELINE DEPLOYED WITH THE DISTAL END STILL STUCK IN THE CAPTURE COIL UPON RETRIEVAL. AN ATTEMPT TO RELEASE THE PIPELINE FROM THE CAPTURE COIL WAS MADE WITH A BALLOON ALSO WITHOUT SUCCESS. FAILED ATTEMPTS TO RETRIEVE THE PIPELINE WERE MADE WITH A SOLITAIRE, MICROVENA SNARE, AND ALLIGATOR RETRIEVAL DEVICE WERE MADE. THE PIPELINE WAS EVENTUALLY PULLED PROXIMALLY WITH THE MICROVENA SNARE AND COVERED THE ANEURYSM. THE ENTIRE PIPELINE SYSTEM WAS LEFT IN PLACE WITH THE DISTAL END STILL STUCK TO THE CAPTURE COIL. SUBSEQUENTLY, THE PATIENT EXPIRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84223 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77425-16 9672425

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death