BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 8156896 · Received December 12, 2018

    Report

    Report Number
    2029214-2018-01055
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    December 3, 2018
    Report Date
    March 20, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    OUT
    UDI-DI
    00847536016262
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PIPELINE FLEX WAS RETURNED WITHIN ITS INNER POUCH; INSIDE OF A SEALED BIO-HAZARD BAG AND A SHIPPING BOX. WHEN COMPARED TO THE DRAWINGS 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. THE DISTAL AND PROXIMAL ENDS OF THE PIPELINE FLEX BRAID FULLY OPENED AND NO DAMAGE. NO BENDS WERE OBSERVED ON THE PUSHWIRE. NO DEFECTS WERE FOUND WITH THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, RE-SHEATHING PAD OR WITH THE PROXIMAL BUMPER. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE CUSTOMER¿S PHOTOS, THE CUSTOMER REPORT OF "FAILURE TO OPEN" WAS CONFIRMED AS THE PIPELINE FLEX APPEARED TO BE NOT OPENED. THE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, BASED ON THE RETURNED DEVICE, THE CUSTOMER COMPLAINT WAS NOT CONFIRMED AS THE RETURNED PIPELINE FLEX WAS FOUND FULLY OPENED WITH NO DAMAGE. POSSIBLE CONTRIBUTING FACTOR OF ¿FAILURE TO OPEN¿ INCLUDES PATIENT TORTUOUS ANATOMY. 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 · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THE DEVICES WERE PREPARED AND FLUSHED AS INDICATED PER THE IFU. THE INNER DIAMETER OF THE HEADWAY-27 WAS 0.027".

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT, AFTER DEPLOYING APPROXIMATELY 10MM OF THE PIPELINE, THEY SAW IT WAS TWISTED IN THE MIDDLE PART OF THE ANEURYSM NECK AND NOT OPENING AT ALL. AS A RESULT THEY TRIED TO RESHEATH BUT THE DEVICE WOULD NOT OPEN AFTER 3 ATTEMPTS. THEN THEY TRIED TO DEPLOY IT MORE AND IT WAS OPENING WELL, BUT APPROXIMATELY 3MM OF THE DEVICE IN THE MIDDLE REMAINED TWISTED. THEY THEN RESHEATED COMPLETELY AND ATTEMPTED TO DEPLOY AGAIN, BUT IT BECAME TWISTED AT THE DISTAL PART. THE DEVICE WAS THEN REMOVED AND THE ANEURYSM COILED WITH 6 GDC COILS, WITH SOME NECK REMAINING AS THE NECK WAS "QUITE WIDE." THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LARGE RIGHT SIDED CAVERNOUS ANEURYSM WITH A MAX DIAMETER OF 13MM AND A NECK DIAMETER OF 7MM. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED BUT THE PRU LEVEL WAS UNKNOWN. THE DEVICES WERE PREPARED AS INDICATED PER THE IFU. IT WAS CONFIRMED THAT THE PIPELINE WAS NOT POSITIONED IN A BEND, AND THAT LESS THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE A HEADWAY-27 MICROCATHETER, 7F-80CM ARROW LONG SHEATH, NEURON 6F GUIDING CATHETER, TRANSCEND .014 GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996176 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA PED-425-30 A624669 00847536016262

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR