BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 11286043 · Received February 5, 2021

    Report

    Report Number
    2029214-2021-00141
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    February 3, 2021
    Report Date
    May 7, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536019751
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE PIPELINE FLEX EMBOLIZATION DEVICE (MODEL: PED-500-25 LOT: B032587) FOUND THAT THE PIPELINE FLEX PUSHWIRE WAS KINKED WITHIN INTRODUCER SHEATH AT ~152.0 CM FROM PROXIMAL END. THE DISTAL HYPOTUBE WAS FOUND TO BE INTACT WITH THE PTFE SHRINK TUBING PULLED BACK. THE PROXIMAL BUMPER, RE-SHEATHING PAD AND RE-SHEATHING MARKER WERE FOUND INTACT. THE DPS RESTRAINTS/SLEEVES APPEARED TO BE IN GOOD CONDITION. THE TIP COIL WAS FOUND TO BE INTACT. DUE TO THE CONDITION IN WHICH THE BRAID WAS RETURNED, THE PROXIMAL AND DISTAL ENDS WERE UNABLE TO BE DETERMINED. BRAID END 1 WAS FOUND TO BE OPENED AND FRAYED. BRAID END 2 WAS FOUND TO BE COLLAPSED AND FRAYED. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL¿ WAS CONFIRMED AS THE PIPELINE FLEX BRAID WAS FOUND TO BE COLLAPSED AND DAMAGED. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. H6: METHOD CODE UPDATED TO B01. 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 A REPORT THAT THE PIPELINE WAS SUCCESSFULLY PLACED IN THE MIDDLE CEREBRAL ARTERY (MCA) IN THE PHENOM MICROCATHETER, AND THEN IT WAS PREPARED TO DEPLOY THE TIP AT THE M1 SEGMENT. THE DISTAL TIP OF THE PIPELINE COULD NOT BE OPENED AFTER SEVERAL ATTEMPTS, AND IT COULD NOT BE OPENED AFTER WITHDRAWN FROM THE INTERNAL CAROTID ARTERY (ICA). AFTER SEVERAL MORE ATTEMPTS, IT STILL FAILED. IN VITRO, THE STENT WAS PUSHED OUT AND THE TIP OF THE PIPELINE WAS SHAPED LIKE A FISH MOUTH. IT WAS NOTED THE PIPELINE WAS NOT POSITIONED IN A BEND AT THE TIME OF DEPLOYMENT, LESS THAN 50% HAD BEEN DEPLOYED, AND RESHEATHING WAS PERFORMED LESS THAN THREE TIMES. A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE PROCEDURE. 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 ANGIOGRAPHIC RESULTS SHOWED BLOOD ENTERING THE ANEURYSM IMMEDIATELY SLOWED DOWN. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) OPHTHALMIC AND CLINOID SEGMENTS WITH A MAX DIAMETER OF 13 MM AND A 7.7 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS UNKNOWN IF DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184151 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-500-25 B032587 00847536019751

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR