BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 11194388 · Received January 19, 2021

    Report

    Report Number
    2029214-2021-00064
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 30, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536019720
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE PIPELINE FLEX BRAID (LOT NO. B041993) FOUND THAT THERE WAS NO PUSHWIRE RETURNED WITH THE DEVICE. THE DISTAL END OF THE PIPELINE FLEX BRAID APPEARED NOT OPENED DUE TO DAMAGED BRAID. THE PROXIMAL OF THE PIPELINE FLEX BRAID WAS FOUND FULLY OPENED AND MODERATELY FRAYED. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX WAS CONFIRMED TO HAVE FAILURE TO OPEN AT THE DISTAL END AS THE DISTAL END WAS NOT OPENED DUE TO DAMAGED BRAID. HOWEVER, THE CAUSE EVENT AND THE CAUSE FOR DAMAGE COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR FAILURE TO OPEN INCLUDE PATIENT TORTUOUS ANATOMY AND DAMAGE TO THE PIPELINE FLEX BRAID. THERE WAS NO NON-CONFORMANCE TO SPECIFICATION THAT MAY HAVE CONTRIBUTED TO THE FAILURE TO OPEN ISSUE. H6: METHOD CODE UPDATED TO B19. RESULT CODE UPDATED TO C070601. CONCLUSION CODE UPDATED TO D15. 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

    NO ADDITIONAL INFORMATION RECEIVED.

    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 INFORMATION REGARDING A PIPELINE WHICH FAILED TO OPEN AT THE DISTAL END AND HAD "RIBBONING." THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED FUSIFORM ANEURYSM OF THE RIGHT INTERNAL CAROTID ARTERY (ICA) CLINOID SEGMENT. THE ANEURYSM MAX DIAMETER WAS 8MM AND THE NECK DIAMETER WAS 8MM. VESSEL TORTUOSITY WAS MINIMAL. IT WAS REPORTED THAT THE PIPELINE AND ALL ACCESSORY DEVICES WERE PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU); THERE WERE NO VISUAL OR PHYSICAL DEFECTS OF THE PIPELINE NOTED DURING PREPARATION. COMPLETE FLUSH ROUTINE OF THE INTRODUCER SHEATH WAS OBSERVED. THE PIPELINE WAS ADVANCED THROUGH THE MICROCATHETER WITHOUT ANY UNUSUAL RESISTANCE TO THE INTENDED LOCATION. WHEN THE PIPELINE WAS APPROXIMATELY 50% DEPLOYED, IT WAS NOTED THAT THE DISTAL END WAS NOT OPENING WELL AND THAT THERE WAS POSSIBLE RIBBONING. THE PIPELINE WAS RE-SHEATHED WITH THE MICROCATHETER AND DEPLOYMENT WAS ATTEMPTED A SECOND TIME WITH THE SAME RESULT OF INCOMPLETE DISTAL OPENING AND RIBBONING OBSERVED, CONFIRMED WITH BILATERAL IMAGING. NO OTHER STEPS WERE TAKEN TO TRY AND OPEN THE PIPELINE. AT THAT TIME THE PIPELINE WAS RESHEATHED AND REMOVED TOGETHER WITH MICROCATHETER FROM THE PATIENT'S BODY AND BOTH WERE REPLACED. A NEW PIPELINE OF THE SAME MODEL AND LOT WAS THEN SUCCESSFULLY IMPLANTED WITHOUT ISSUE. IT WAS NOTED THAT THE PATIENT DID NOT HAVE ANY EXCESSIVE OR ABNORMAL VESSEL TORTUOSITY BUT THAT THE MIDDLE SECTION OF THE PIPELINE WAS POSITIONED IN A VESSEL BEND. THERE WAS NO HARM OR INJURY TO THE PATIENT. POST-PROCEDURE ANGIOGRAPHY REVEALED SUCCESSFULLY PLACEMENT OF THE SUBSEQUENT/REPLACEMENT PIPELINE. ANCILLARY DEVICES: PHENOM-27 150CM MICROCATHETER, NEURONMAX 80CM SHEATH, PHENOM PLUS 120CM GUIDE CATHETER, FATHOM 0.016" GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89954 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-500-20 B041993 00847536019720

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR