BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX EMBOLIZATION DEVICE

    MDR report key: 7991927 · Received October 22, 2018

    Report

    Report Number
    2029214-2018-00871
    Event Type
    Malfunction
    Date Received
    October 22, 2018
    Date of Event
    August 17, 2018
    Report Date
    October 25, 2018
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. THE DEVICE WAS NOT RETURNED; THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED FROM THE REPORTED INFORMATION. D. SUSPECT MEDICAL DEVICE BRAND NAME: PIPELINE FLEX WITH SHIELD TECHNOLOGY MODEL NUMBER: PED2-400-12. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    BASED UPON THE NEW INFORMATION RECEIVED, THIS WOULD NOT MEET THE CRITERIA FOR A REPORTABLE EVENT AS THE PIPELINE FLEX WITH SHIELD TECHNOLOGY DEVICE WAS NOT FAILURE TO OPEN DURING THE PROCEDURE. THERE WAS NOT DEVICE MALFUNCTION. THE PHYSICIAN USED GUIDEWIRE TO OPTIMIZE FULL WALL APPOSITION. PER OUR INSTRUCTIONS FOR USE (IFU): CAREFULLY INSPECT THE DEPLOYED PIPELINE FLEX WITH SHIELD TECHNOLOGY EMBOLIZATION DEVICE UNDER F LUOROSCOPY TO CONFIRM THAT IT IS COMPLETELY APPOSED TO THE VESSEL WALL AND NOT KINKED. IF THE DEVICE IS NOT FULLY APPOSED OR IS KINKED, CONSIDER USING A BALLOON CATHETER, MICRO CATHETER, OR GUIDE-WIRE TO FULLY OPEN IT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A PIPELINE FLEX WITH SHIELD DID NOT OPEN DURING A PROCEDURE. IT WAS REPORTED THAT A GUIDEWIRE WAS USED TO ASSIST A PIPELINE TO OPEN. THE PIPELINE DEVICE WAS ABLE TO BE PLACED AND COVERED TWO ANEURYSMS. POST PROCEDURAL IMAGING SHOWED COMPLETE STASIS WITH CLASS 3 ANEURYSM OCCLUSION. THE PATIENT WAS DISCHARGED HOME THREE DAYS POST PROCEDURE FOR SELF CARE. THE PATIENT WAS UNDERGOING PIPELINE PLACEMENT IN THE TREATMENT OF A PREVIOUSLY RUPTURED SACCULAR SIDEWALL ANEURYSM MEASURING 10MM X 6MM X 10MM X 2MM (DIA, HGT, WTH, NCK) LOCATED IN THE RIGHT C7 COMMUNICATING SEGMENT. THE DISTAL AND PROXIMAL DIAMETER OF THE PARENT ARTERY WAS 3.8MM X 4.1MM.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED FROM CLINICAL SITE THAT THE DEVICE DID NOT FAIL TO OPEN. THE GUIDEWIRE WAS USED TO OPTIMIZE FULL WALL APPOSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834221 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PED-400-12 A353063

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR