BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 20080081 · Received August 27, 2024

    Report

    Report Number
    2029214-2024-01486
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 23, 2024
    Report Date
    October 29, 2024
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: THE DISTAL TIP OF THE APOLLO CATHETER WAS FOUND TO BE DETACHED AND WAS NOT RETURNED. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE VESSEL TORTUOISTY WAS MODERATE. THE PATIENT WAS BEING TREATED FOR A LESION IN THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA). THERE WERE NO RELATED SYMPTOMS RELATED TO TIP PRE-DETACHMENT. NO ACTIONS WERE PREFORMED TO RESOLVE THE TIP PRE-DETACHMENT. THE CAUSE OF THE DETACHMENT WAS NOT DETERMINED. TIP DETACHMENT OCCURED DURING NAVIGATION THROUGH THE GUIDE CATHETER. THERE WAS NO RESISTANCE WHEN THE APOLLO CATHETER WAS BEING ADVANCED OR RETRIEVED. THE APOLLO TIP IS IN THE DISTAL ACA. THERE IS NO FUTURE PLANS TO RETRIEVE THE CATHETER TIP. THERE WAS NO VESSEL CALCIFICATION. THERE WAS NO DAMAGE TO ANY DEVICES.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT AN APOLLO CATHETER TIP WAS PRE-DETACHED. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION. THE TIP WILL NOT BE RETURNED WITH THE CATHETER FOR INVESTIGATION AS IT WAS IMPLANTED IN THE PATIENT¿S BODY. NO FORCE APPLIED DURING REMOVAL. THE CATHETER TIP WAS NOT ENTRAPPED / STUCK. THERE WAS NO VASOSPASM. THERE WAS NO SURGICAL OR MEDICINAL INTERVENTION REQUIRED. THIS DID NOT OCCUR DURING ONYX INJECTION. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198044 APOLLO AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-5096-000 B544632

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown