BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 12087137 · Received June 29, 2021

    Report

    Report Number
    2029214-2021-00789
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    June 23, 2021
    Report Date
    October 13, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    UDI-DI
    00847536006041
    PMA / PMN Number
    P030004/S006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: VISUAL INSPECTION/DAMAGE LOCATION DETAILS: NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE APOLLO MICRO CATHETER HUB. THE MICRO CATHETER BODY WAS FOUND STRETCHED/RUPTURED AT ~149.6CM FROM THE PROXIMAL END. THE DISTAL TIP AND MARKER BAND WAS FOUND CRUSHED. TESTING/ANALYSIS: THE APOLLO TOTAL LENGTH WAS MEASURED TO BE ~168.8CM, THE USABLE LENGTH WAS MEASURED TO BE ~162.6CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION 165.0CM ± 2.5CM). THE DETACHABLE TIP WAS MEASURED TO BE ~3.1CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 3.0CM ± 0.3CM). THE APOLLO MICRO CATHETER WAS FLUSHED, AND WATER DID NOT EXIT THE DISTAL TIP OR RUPTURE AS IT WAS FOUND OCCLUDED. AN IN-HOUSE 0.010¿ MANDREL WAS INSERTED INTO THE APOLLO MICRO CATHETER BECAME STUCK AT ~88.2CM FROM THE PROXIMAL END. THE CATHETER WAS CUT, AND DRIED CONTRAST WAS FOUND AT THE STUCK LOCATION. NO OTHER ANOMALIES WERE OBSERVED. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER RUPTURE WITH ANGIO¿ WAS CONFIRMED. POSSIBLE CAUSES OF FAILURE INCLUDE INJECTION WHILE THE DISTAL PORTION OF CATHETER IS KINKED/PROLAPSED/OCCLUDED, WRONG TYPE OF SYRINGE TO USE WITH SALINE/CONTRAST OR USE OF POWER INJECTOR. THE DISTAL TIP WAS FOUND CRUSHED WHICH IS A POSSIBLE CAUSE OF THE RUPTURE. AS THE REMAINING CONTRAST WITHIN THE MICRO CATHETER SOLIDIFIED FOLLOWING THE PROCEDURE, IT IS NOT POSSIBLE TO CONFIRM. IT IS ALSO NOT POSSIBLE TO CONFIRM WHETHER THE CONTRAST HAD SOLIDIFIED DURING THE PROCEDURE. THERE WAS NO INDICATION THAT THE EVENT WAS RELATED TO A POTENTIAL MANUFACTURING ISSUE. 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 WAS RECEIVED FROM THE REP ON 2021-JUL-07. IT WAS REPORTED THAT ¿THE INJECTION WAS WITH CONTRAST ACCORDING TO THE CLINICIAN AT THE ACCOUNT AND THEIR ONLY AS WAS A REPLACEMENT. THEY DID NOT MENTION THAT THE TIP WAS LEFT BEHIND.¿

    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 AFTER USING A 3CC SYRINGE, THE PHYSICIAN INJECTED THROUGH THE APOLLO CATHETER AND RUPTURED THE DEVICE. THE RUPTURE WITH ANGIO OCCURRED IN THE DISTAL PART OF THE CATHETER. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE CATHETER WAS REPLACED, AND 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 EMBOLIZATION WITH ONYX LIQUID EMBOLIC. THE ACCESS VESSEL DIAMETER WAS UNKNOWN, BUT IT WAS LARGER THAN THE APOLLO DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981021 APOLLO AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-5096-000 B088023 00847536006041

    Patients

    Seq Age Sex Outcome Treatment
    1