BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 12833170 · Received November 17, 2021

    Report

    Report Number
    2029214-2021-01494
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    August 3, 2021
    Report Date
    November 17, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536016088
    PMA / PMN Number
    P100018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PIPELINE FLEX EMBOLIZATION DEVICE AND A PHENOM-27 CATHETER WERE RETURNED FOR ANALYSIS. THE INNER DIAMETER (ID) OF THE PHENOM-27 CATHETER WAS FOUND TO BE 0.027¿. PER PIPELINE FLEX EMBOLIZATION DEVICE INSTRUCTIONS FOR USE (IFU): ¿THE PIPELINE EMBOLIZATION DEVICE IS DESIGNED TO BE DELIVERED THROUGH A COMPATIBLE MICRO CATHETER OF 0.027¿ INSIDE DIAMETER. THEREFORE, THE PHENOM-27 CATHETER WAS FOUND TO BE COMPATIBLE FOR USE WITH THE PIPELINE FLEX. THE PIPELINE FLEX PUSHWIRE WAS FOUND TO BE EXTENDING ~58.5CM FROM HUB. THE PIPELINE FLEX EMBOLIZATION DEVICE WAS THEN REMOVED FROM THE PHENOM-27 CATHETER. NO BENDS OR KINKS WERE FOUND WITH THE PIPELINE PUSHWIRE. THE HYPOTUBE WAS FOUND TO BE INTACT WITH PTFE PULLED BACK AND BLOOD RESIDUE. THE PROXIMAL BUMPER, RE-SHEATHING MARKER AND RE-SHEATHING PAD WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND TO BE DAMAGED. THE TIP COIL WAS FOUND TO BE DAMAGED. THE PIPELINE BRAID WAS NOT RETURNED. NO OTHER ANOMALIES WERE FOUND WITH THE PIPELINE DEVICE. THE PIPELINE FLEX PUSHWIRE WAS FOUND TO BE EXTENDING ~58.5CM FROM HUB. NO DAMAGES WERE FOUND WITH THE PHENOM HUB. THE PHENOM TOTAL LENGTH WAS MEASURED TO BE ~151.7CM. THE USEABLE LENGTH WAS MEASURED TO BE ~145.2CM WHICH WAS FOUND TO BE WITHIN SPECIFICATION. THE CATHETER BODY WAS FOUND TO BE ACCORDIONED AT ~145.0CM FOR ~5.0CM FROM DISTAL TIP. NO DAMAGES WERE FOUND WITH THE DISTAL TIP. THE PIPELINE FLEX WAS THEN REMOVED FROM THE CATHETER. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER RESISTANCE¿ WAS CONFIRMED. IT IS LIKELY THE DAMAGES TO THE CATHETER BODY (ACCORDIONED) CONTRIBUTED TO THE RESISTANCE. POSSIBLE CONTRIBUTING FACTORS TO ¿CATHETER RESISTANCE¿ INCLUDE THE USE OF AN INCOMPATIBLE DEVICE, SEVERELY TORTUOUS PATIENT ANATOMY, AND INSUFFICIENT CATHETER FLUSH. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿DELIVERY SYSTEM STUCK DURING RETRACTION¿ WAS CONFIRMED. IT IS LIKELY THE DAMAGES TO THE CATHETER BODY (ACCORDIONED) CONTRIBUTED TO THE RESISTANCE. POSSIBLE CONTRIBUTING FACTORS TO ¿DELIVERY SYSTEM STUCK DURING RETRACTION¿ INCLUDE HIGH FORCE DELIVERY/RETRIEVAL, CATHETER DAMAGE, AND LACK OF A CONTINUOUS FLUSH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE DELIVERY SYSTEM BECAME STUCK IN THE PHENOM MICROCATHETER DURING RETRACTION. THE PATIENT WAS UNDERGOING TREATMENT FOR UNRUPTURED, SACCULAR ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT ICA. THE MAX DIAMETER WAS 6MM, AND THE NECK DIAMETER WAS 4MM. THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 3.2MM DISTAL AND 4.2MM PROXIMAL. THE ACCESS VESSEL WAS THE LEFT ICA, WHICH WAS 4.2MM IN DIAMETER. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED, AND THE PRU LEVEL WAS 26. IT WAS REPORTED THAT THE PIPELINE WAS SUCCESSFULLY DEPLOYED ACROSS THE ANEURYSM. THE PHYSICIAN WENT THROUGH THE DEVICE TO CAPTURE THE DISTAL PIPELINE WIRE. RETRIEVAL WAS TOUGH, AND THE WIRE BECAME STUCK IN THE CATHETER. THE WIRE AND CATHETER WERE REMOVED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE PUSHWIRE WAS NOT ROTATED DURING REMOVAL, AND THERE WAS NO DAMAGE TO THE CATHETER. ANGIOGRAPHIC RESULTS POST PROCEDURE SHOWED GOOD PLACEMENT. THE PATIENT WOKE UP WITHOUT INCIDENT AND RETURNED TO BASELINE. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A NAVIEN 072 GUIDE CATHETER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PIPELINE WIRE BECAME STUCK IN THE DISTAL PORTION OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724356 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-425-12 B111802 00847536016088

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female