BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 8223317 · Received January 7, 2019

    Report

    Report Number
    2029214-2019-00019
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 11, 2018
    Report Date
    March 18, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    OUT
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION - ADDITIONAL INFORMATION. DATE MFR REC ¿ ADDITIONAL INFORMATION. TYPE OF FOLLOW UP - DEVICE EVALUATION. DEVICE EVALUATED BY MANUFACTURER- ADDITIONAL INFORMATION. CODES UPDATED AS RECEIVED, THE PIPELINE FLEX PUSHWIRE WAS RETURNED WITHOUT THE PIPELINE FLEX BRAID. THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE DISTAL HYPOTUBE AND PTFE SHRINK TUBING WERE FOUND TO BE INTACT WITH NO SIGNS OF ELONGATION. NO BEND WAS FOUND ON THE PUSHWIRE. NO DAMAGES WERE FOUND WITH THE CATHETER, TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, RE-SHEATHING PAD OR WITH THE PROXIMAL BUMPER. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS WE WERE UNABLE TO DETERMINE THE CAUSE OF "FAILURE TO OPEN AT THE DISTAL END". PIPELINE FLEX BRAID WAS NOT RETURNED; THEREFORE, ANY CONTRIBUTING FACTORS FROM THE BRAID COULD NOT BE ASSESSED. HOWEVER, BASED ON THE CUSTOMER'S PHOTOS, THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE DISTAL END OF THE BRAID APPEARED TO BE NOT OPENED. 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.

    Additional Manufacturer Narrative · 1

    THE PIPELINE HAS NOT BEEN RETURNED FOR EVALUATION; PRODUCT ANALYSIS CANNOT BE PERFORMED. THE DEVICE WAS NOT RETURNED, THEREFORE THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CAUSE OF THE EVENT CANNOT BE CONCLUSIVELY DETERMINED FROM THE PROVIDED INFORMATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT THE PIPELINE DID NOT OPEN DISTALLY AFTER SEVERAL ATTEMPTS. THE OPENING WAS IN HOURGLASS SHAPE. THE DEVICE WAS RETRIEVED, AND A COMPETITOR DEVICE WAS USED TO TREAT THE PATIENT. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16377 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PED-500-18 A442198

    Patients

    Seq Age Sex Outcome Treatment
    1