BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 11155713 · Received January 12, 2021

    Report

    Report Number
    2029214-2021-00042
    Event Type
    Malfunction
    Date Received
    January 12, 2021
    Date of Event
    January 8, 2021
    Report Date
    January 12, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536016354
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO DAMAGE TO THE PUSHER WIRE. IT WAS NOT THAT THE STENT WAS PARTIALLY PROLAPSED FROM PULLING THROUGH THE PHENOM 27.

    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 THE 425-14 PIPELINE (LOT #: A981286) WAS INSERTED INTO THE PHENOM MICROCATHETER AND FLUSHED CORRECTLY. THE PHYSICIAN ADVANCED THE DEVICE INTO THE PHENOM FURTHER, AND AFTER ABOUT 25 CM, RESISTANCE WAS FELT IN THE MIDDLE SEGMENT AND THE DEVICE COULD NOT BE PUSHED ANY FURTHER. THE DEVICE WAS REMOVED, THE PHENOM WAS CHECKED FOR INTEGRITY AND FLUSHED, AND THEN A NEW PIPELINE OF THE SAME SIZE AND DIAMETER WAS USED WITHOUT ISSUE. THERE WAS NO DAMAGE TO THE CATHETER, AND IT WAS UNKNOWN IF THERE WAS ANY DAMAGE TO THE PUSHWIRE. AFTER IMPLANTING THE 425-14 PIPELINE, THE PHYSICIAN WANTED TO IMPLANT A SECOND DEVICE MORE PROXIMAL. A 450-12 PIPELINE (LOT #: A908288) WAS ADVANCED WITH NO RESISTANCE AND INITIALLY DEPLOYED ABOUT 7-8 MM, BUT THE DISTAL PORTION OF THE DEVICE FAILED TO OPEN. RESHEATHING AND REDEPLOYMENT WAS PERFORMED THREE TIMES, BUT THE DISTAL SEGMENT STILL FAILED TO OPEN. THE PIPELINE WAS THEN REMOVED WITH THE PHENOM MICROCATHETER, AND ANOTHER PIPELINE (450-12) WAS USED. IT WAS NOTED THE MIDDLE AND DISTAL SEGMENTS OF THE DEVICE WERE POSITIONED IN A BEND. THE SECOND 450-12 PIPELINE (LOT #: B080639) EXPERIENCED THE SAME ISSUE: THE DISTAL SEGMENT FAILED TO OPEN. THIS PIPELINE WAS REMOVED AND A 450-14 PIPELINE WAS THEN USED TO COMPLETE THE PROCEDURE WITH NO FURTHER ISSUES REPORTED. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHY SHOWED SUCCESSFUL DEPLOYMENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE SUPERIOR HYPOTHESEAL OPHTHALMIC ARTERY SE GMENT WITH A MAX DIAMETER OF 6 MM AND A 3 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, AND THE PLATELET REACTIVITY UNITS (PRU) LEVEL WAS 170. ANCILLARY DEVICES INCLUDE A NEURON MAX 088 SHEATH, NAVIEN 072 GUIDECATHETER, PHENOM 27 MICROCATHETER, SYNCHRO2 SOFT GUIDEWIRE. REFER TO MANUFACTURER REPORT 2029214-2021-00041 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51974 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-450-12 B080639 00847536016354

    Patients

    Seq Age Sex Outcome Treatment
    1