BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE VANTAGE WITH SHIELD TECHNOLOGY

    MDR report key: 19254717 · Received May 6, 2024

    Report

    Report Number
    2029214-2024-00867
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    March 12, 2024
    Report Date
    May 6, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3:EQUIPMENT USED: VIDEO INSPECTION SYSTEM (M-85519), RULER (M-83360), 0.0265¿ MANDREL DRAWING(S) REFERENCED: (B)(4) REV. F AS FOUND CONDITION: THE PIPELINE VANTAGE DEVICE AND PHENOM-27 MICRO CATHETER WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN TWO SEALED PLASTIC BIOHAZARD POUCHES; WITHIN AN OPENED PIPELINE VANTAGE OUTER CARTON AND WITHIN AN OPENED PIPELINE VANTAGE INNER POUCH. A SECOND SET OF PIPELINE VANTAGE DEVICE AND PHENOM-27 MICRO CATHETER WERE ALSO RETURNED AND WILL BE ANALYZED IN PLI-30 AND PLI-40. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO DAMAGES WERE FOUND WITH THE INTRODUCER SHEATH. A LARGE AMOUNT OF COAGULATED BLOOD WAS FOUND WITHIN THE INTRODUCER SHEATH (FIGURE G). THE PIPELINE VANTAGE PUSHER WAS FOUND MOSTLY WITHIN THE SHEATH WITH THE DISTAL DELIVERY WIRE EXTENDING OUT THE DISTAL END OF THE SHEATH (FIGURE H). THE SHEATH WAS FOUND NOT FULLY SEATED IN THE HUB. THE BRAID WAS FOUND PARTIALLY RETRACTED OUT OF THE HUB (FIGURE H). NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE PROXIMAL PUSHER. THE HYPOTUBE WAS FOUND INTACT AND UNSTRETCHED AND PTFE SHRINK TUBING WAS STILL INTACT. NO DAMAGES WERE FOUND WITH THE SPACERS, ADVANCE RESHEATHING MECHANISM (ARMS), PROXIMAL BUMPER, OR SUPPORTING DISKS. THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE DAMAGED (FIGURE Q). NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE TIP COIL. DRIED BLOOD WAS FOUND THROUGHOUT THE MICRO CATHETER AND ON THE DISTAL BRAID (FIGURE N). ONCE THE BLOOD WAS DISSOLVED, BOTH BRAID ENDS WERE FOUND FULLY OPENED, DAMAGED, AND FRAYED (FIGURE M AND O). NO DAMAGES WERE FOUND WITH THE PHENOM-27 HUB. THE MICRO CATHETER BODY WAS FOUND KINKED AT ~3.5CM FROM THE DISTAL END. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE PHENOM-27 MICRO CATHETER TIP AND MARKER BANDS. TESTING/ANALYSIS: THE PIPELINE BRAID AND DISTAL DELIVERY WIRE WAS REMOVED USING TWEEZERS, THE PIPELINE VANTAGE COULD NOT BE USED FOR RESISTANCE TESTING DUE TO THE DAMAGED CONDITION AND DUE TO THE BRAID ALREADY DEPLOYED IN THE HUB. THE PHENOM-27 TOTAL LENGTH WAS MEASURED TO BE ~158.6CM AND THE USABLE LENGTH WAS MEASURED TO BE ~152.2CM, WHICH IS WITHIN SPECIFICATION (SPECIFICATION: TOTAL (REF) = 165.5CM, USABLE = 150CM ± 5CM). THE PHENOM-27 MICRO CATHETER WAS FLUSHED, AND WATER FAILED TO EXIT THE DISTAL END. AN IN-HOUSE MANDREL WAS INSERTED INTO THE HUB AND BECAME STUCK AT ~3.0CM FROM THE PROXIMAL END. THE CAUSE OF THE RESISTANCE WAS FOUND TO BE THE DRIED BLOOD. CONCLUSION: BASED ON THE ANALYSIS FINDINGS, THE CUSTOMER REPORT OF ¿RESISTANCE/STUCK IN CATHETER¿ AND ¿CATHETER RESISTANCE¿ WAS CONFIRMED. THE CAUSE OF THE RESISTANCE DURING IN-HOUSE TESTING WAS FOUND TO BE THE COAGULATED BLOOD FOUND. IT IS POSSIBLE INSUFFICIENT CONTINUOUS FLUSH WAS USED DURING THE PROCEDURE, CAUSING THE BLOOD TO BACKFLOW UP THE MICRO CATHETER AND INTO THE INTRODUCER SHEATH. IT IS POSSIBLE THE DAMAGED DPS SLEEVES CONTRIBUTED TOWARDS THE RESISTANCE. IT IS ALSO POSSIBLE THE CONFIRMED ¿CATHETER KINK/DAMAGE¿ FOUND ON THE DISTAL MICRO CATHETER CONTRIBUTED TOWARDS THE RESISTANCE. POSSIBLE CAUSES FOR CATHETER KINK ARE PATIENT VESSEL TORTUOSITY, DEVICE REMOVED AGGRESSIVELY, CATHETER ENTRAPMENT OR USER ADVANCES/RETRIEVES DEVICE AGAINST RESISTANCE. CUSTOMER REPORTED CONTINUOUS FLUSH WAS USED, DEVICES WERE PREPARED PER IFU, AND VESSEL TORTUOSITY AS SEVERE. IT IS LIKELY THE SEVERE TORTUOSITY CONTRIBUTED TOWARDS THE RESISTANCE AND CATHETER KINK. IT IS POSSIBLE THE REPORTED FAILURE TO RESHEATH IS DUE TO THE SHEATH NOT FULLY SEATED IN THE HUB DURING RETRACTION, CAUSING THE BRAID TO SEPARATE FROM THE ARMS AND BECOME STUCK IN THE HUB. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE ACCESS WAS LOST AND FOR REPOSITIONING THE HEALTHCARE PROVIDER (HCP) HAD TO RETRIEVE THE PIPELINE (LOT B674478) FLOW DIVERTER (FD). IT WAS NOT POSSIBLE, THE FD WAS STUCK IN THE MICROCATHETER. HCP RETRIEVED THE WHOLE SYSTEM. THE RESISTANCE OCCURRED IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THE PIPELINE BECAME STUCK IN THE MIDDLE OF THE MICROCATHETER DURING RETRIEVAL. THE HCP RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE , BUT THE ISSUE DID NOT RESOLVE. IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO UNSHEATH OR RESHEATH THE FD IN THE MICROCATHETER (LOT 227159095). IT WAS NOT POSSIBLE TO RETRIEVE THE FD. THERE WAS CATHETER RESISTANCE IN THE DISTAL PORTION. THE CATHETER WAS KINKED IN THE DISTAL PORTION. IT WAS REPORTED THAT THE PHENOM (LOT 226990778) WAS KINKED AND IT WAS NOT POSSIBLE TO RETRIEVE THE FD. IT WAS REPORTED THAT THE IT WAS NOT POSSIBLE TO UNSHEATH OR RESHEATH THE PIPELINE (LOT B292529) IN THE MICROCATHETER, SO IT WAS NOT POSSIBLE TO REPLACE THE FD. THE RESISTANCE OCCURRED IN THE DISTAL PORTION OF THE CATHETER. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE PIPELINE WAS USED FOR AN APPROVED INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, INTERNAL CAROTID ARTERY (ICA) CAVERNOUS RIGHT ANEURYSM WITH A MAX DIAMETER OF 11MM AND A 7MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. ANGIOGRAPHIC RESULT POST-PROCEDURE WAS OKAY. ANCILLARY DEVICES INCLUDE A NEUROMAX SHEATH, SOPHIA GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777591 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER OUT MICRO THERAPEUTICS, INC. DBA EV3 PED3-027-500-14 B674478

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female