BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 11685924 · Received April 19, 2021

    Report

    Report Number
    2029214-2021-00452
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    April 14, 2021
    Report Date
    August 19, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004/S006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE APOLLO MICRO CATHETER WAS RETURNED FOR ANALYSIS. LIQUID EMBOLIC RESIDE WAS FOUND WITHIN THE APOLLO CATHETER HUB. NO DAMAGE WAS FOUND WITH THE APOLLO HUB. NO BENDS OR KINKS WERE FOUND WITH THE APOLLO MICRO CATHETER BODY. THE APOLLO DETACHABLE TIP WAS FOUND TO BE DETACHED FROM THE APOLLO. THE DETACHED TIP WAS NOT RETURNED. THE APOLLO MICRO CATHETER TOTAL LENGTH WAS MEASURED TO BE ~169.8CM, THE USABLE LENGTH WAS MEASURED TO BE ~163.2CM, AND THE DISTAL FLOPPY SEGMENT WAS MEASURED TO BE ~25.7CM. IT COULD NOT BE DETERMINED IF THE APOLLO USEABLE OR DISTAL FLOPPY SEGMENT LENGTHS MET SPECIFICATION AS THE TIP WAS FOUND TO BE DETACHED. THE LDPE COUPLING TUBE OVERLAP LENGTH WAS MEASURED TO BE 1.6MM WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 1.0MM - 2.5MM). BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿TIP PREMATURE DETACHMENT¿ WAS CONFIRMED. TIP PREMATURE DETACHMENT CAN OCCUR IF THE MICRO CATHETER IS REPOSITIONED AFTER THE START OF ONYX INJECTION OR DETACH JOINT LDPE OVERLAP LENGTH TOO SHORT. HOWEVER, THE DETACH JOINT LDPE OVERLAP LENGTH WAS MEASURED TO BE WITHIN SPECIFICATIONS. IN ADDITION, PER THE DHR REVIEW, THE TIP DETACHMENT TENSILE VALUE WAS FOUND TO BE WITHIN CONTROL LIMITS OF HISTORICAL SPC DATA AND SPECIFICATIONS. TIP PREMATURE DETACHMENT CAN ALSO OCCUR DUE TO REPOSITIONING OF THE MICRO CATHETER WHILE IT IS IN A WEDGED POSITION OR WITH VESSELS THAT ARE IN VASOSPASM. HOWEVER, THE CAUSE FOR THE TIP DETACHMENT COULD NOT BE CONFIRMED. 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.

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MARKER BAND WAS NOT MISSING WHEN THE DEVICE WAS OPENED. THE TRANSITION ZONE OF DETACHMENT WAS PERCEIVED BY THE NEUROSURGEON DURING THE PREPARATION OF THE MATERIAL ON THE SUPPORT TABLE. DURING FLUOROSCOPY, THEY OBSERVED ONLY A RADIOPAQUE MARK. THERE WAS NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

    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 APOLLO CATHETER DID NOT HAVE THE 02 RADIOPAQUE MARKER AT THE END OF THE PRODUCT. ONLY THE 01 MARK 1.5CM FROM THE DETACHABLE TIP WAS APPARENT IN IMAGING. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING LIQUID EMBOLIZATION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586945 APOLLO AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-5095-000 A770515

    Patients

    Seq Age Sex Outcome Treatment
    1