BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX W/SHIELD TECHNOLOGY

    MDR report key: 8341558 · Received February 14, 2019

    Report

    Report Number
    2029214-2019-00118
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    October 29, 2018
    Report Date
    March 8, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED THE FOLLOWING SECTIONS WITH NEW INFORMATION- B5 WITH EVENT DETAILS, AND H6 WITH DEVICE CODE. RECEIVED ADDITIONAL INFORMATION THAT A GUIDEWIRE WAS NOT USED TO OPEN THE PIPELINE DEVICE. THEREFORE, THIS EVENT IS NO LONGER REPORTABLE. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX WITH SHIELD REQUIRED HELP OF A GUIDEWIRE TO FULLY OPEN DURING A PROCEDURE. THERE WAS SIGNIFICANT STASIS WITH ROY AND RAYMOND CLASS 3. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. RECEIVED INFORMATION THAT A GUIDEWIRE WAS NOT USED TO OPEN THE PIPELINE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR SIDEWALL ANEURYSM MEASURING 6.9 MM X 5.5 MM WITH A 4.4 MM NECK LOCATED IN THE SIDEWALL OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE DISTAL AND PROXIMAL LANDING ZONE WAS 2.9 MM X 3.1 MM

    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. SUSPECT MEDICAL DEVICE BRAND NAME: PIPELINE FLEX WITH SHIELD TECHNOLOGY MODEL NUMBER: PED2-325-12. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE PIPELINE FLEX WITH SHIELD REQUIRED HELP OF A GUIDEWIRE TO FULLY OPEN DURING A PROCEDURE. THERE WAS SIGNIFICANT STASIS WITH ROY AND RAYMOND CLASS 3. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE. THE PATIENT WAS UNDERGOING EMBOLIZATION TREATMENT OF AN UNRUPTURED SACCULAR SIDEWALL ANEURYSM MEASURING 6.9 MM X 5.5 MM WITH A 4.4 MM NECK LOCATED IN THE SIDEWALL OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA). THE DISTAL AND PROXIMAL LANDING ZONE WAS 2.9 MM X 3.1 MM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132429 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PED2-325-12 A401985

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR