BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APOLLO

    MDR report key: 6931231 · Received October 9, 2017

    Report

    Report Number
    2029214-2017-01125
    Event Type
    Injury
    Date Received
    October 9, 2017
    Date of Event
    September 15, 2017
    Report Date
    December 7, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004.S006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROCATHETER WAS RETURNED FOR ANALYSIS. A PORTION OF THE MICROCATHETER WAS RETURNED WITHIN A GLASS VIAL. THE MICROCATHETER WAS RETURNED SEPARATED INTO TWO SEGMENTS. APPROXIMATELY 1.5 CM OF THE MICRO CATHETER¿S DISTAL SEGMENT AND THE 1.5 CM DETACHABLE TIP WERE FOUND TO BE SEPARATED FROM THE MICROCATHETER. THESE SEGMENTS WERE NOT RETURNED FOR ANALYSIS, AS THEY REMAIN WITHIN THE PATIENT. THE MICROCATHETER WAS FOUND TO HAVE SEPARATED AT THE PROXIMAL AND DISTAL SHAFT FUSE JOINT. IN ADDITION, THE MICROCATHETER APPEARS TO HAVE ALSO SEPARATED PROXIMAL TO THE PROXIMAL MARKER BAND. LIQUID EMBOLIC MATERIAL RESIDUE WAS FOUND WITHIN THE MICROCATHETER HUB. THE MICROCATHETER¿S PROXIMAL AND DISTAL SEGMENTS WERE BOTH FOUND TO HAVE STRETCHING DAMAGE. THE TUBING MATERIAL OF THE MICROCATHETER¿S SEPARATED ENDS ALSO EXHIBITED STRETCHING AND JAGGED EDGES WITHIN THE INNER ELLIPTICAL WIRE EXPOSED. THE MICROCATHETER WAS RETURNED FOR ANALYSIS. LIQUID EMBOLIC MATERIAL RESIDUE WAS FOUND WITHIN THE MICROCATHETER. THE REMAINING LIQUID EMBOLIC MATERIAL WAS NOT RETURNED FOR ANALYSIS, AS IT WAS CONSUMED IN THE EVENT. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE LIQUID EMBOLIC MATERIAL WAS DEFECTIVE. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE REPORT OF CATHETER SEPARATION DUE TO LIQUID EMBOLIC MATERIAL ENTRAPMENT WAS CONFIRMED, AS THE MICROCATHETER WAS RETURNED SEPARATED INTO TWO SEGMENTS. IT IS LIKELY THAT THE OF LIQUID EMBOLIC MATERIAL REFLUX AND THE PATIENT¿S SEVERE VESSEL ANATOMY MAY HAVE CONTRIBUTED TO THE ENTRAPMENT AND DIFFICULT REMOVAL OF THE MICROCATHETER. ALTHOUGH, IT WAS REPORTED THERE WAS NO FORCE APPLIED TO REMOVE THE ENTRAPPED MICROCATHETER, DAMAGES FOUND WITH THE RETURNED MICRO CATHETER (STRETCHING) INDICATES EXCESSIVE PULLING FORCE WAS USED, CAUSING THE MICROCATHETER TO SEPARATE WHEN THE TENSILE STRENGTH OF THE TUBING MATERIAL WAS EXCEEDED. THIS TYPE OF DAMAGE INDICATES THE MICR OCATHETER WAS LIKELY PULLED BEYOND THE 20 CM LIMIT NOTED IN THE INSTRUCTIONS FOR USE, WHEN THE DEVICE INITIALLY SEPARATED. DURING ATTEMPTS TO RETRIEVE THE RETAINED PORTION OF THE MICROCATHETER FROM WITHIN THE PATIENT, THE MICROCATHETER SEPARATED A SECOND TIME. IT IS POSSIBLE THE OBSERVED VASOSPASM CONTRIBUTED TO THE DIFFICULT REMOVAL OF THE RETAINED PORTION OF THE MICROCATHETER. THE LOT HISTORY RECORD SHOWED NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. PER THE MICROCATHETER INSTRUCTIONS FOR USE (IFU): ¿REGARDLESS OF THE LIQUID EMBOLIC BEING USED, LEAVE A GAP BETWEEN THE REFLUX AND THE PROXIMAL MARKER BAND. EXCESSIVE REFLUX MAY RESULT IN DIFFICULT CATHETER REMOVAL. DO NOT APPLY MORE THAN 20 CM OF TRACTION TO CATHETER TO MINIMIZE RISK OF CATHETER SEPARATION, PROXIMAL TO THE DETACHMENT ZONE.¿ PER THE LIQUID EMBOLIC MATERIAL IFU: ¿DO NOT ALLOW MORE THAN 1 CM OF THE LIQUID EMBOLIC MATERIAL TO REFLUX BACK OVER CATHETER TIP. ANGIOARCHITECTURE, VASOSPASM, EXCESSIVE LIQUID EMBOLIC MATERIAL REFLUX, OR PROLONGED INJECTION TIME MAY RESULT IN DIFFICULT CATHETER REMOVAL AND POTENTIAL ENTRAPMENT.¿ IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION (ID, WEIGHT, AND AGE) WAS UNAVAILABLE FROM THE SITE. THE CATHETER IS EXPECTED TO RETURN FOR EVALUATION. ONCE RECEIVED AND EVALUATION COMPLETED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MDRS FROM THIS EVENT: 2029214-2017-01164, AND 2029214-2017-01127. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: MDRS FROM THIS EVENT: 2029214-2017-01125, 2029214-2017-01126, AND 2029214-2017-01127 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT AFTER ONYX EMBOLIZATION, THE APOLLO CATHETER COULD NOT BE REMOVED; IT REPORTEDLY BROKE AND 25 CM STAYED IN THE PATIENT. AN ATTEMPT WAS MADE TO REMOVE IT WITH A SNARE BUT IT WAS UNSUCCESSFUL. SURGERY WAS THEN PERFORMED AND PART OF THE CATHETER WAS REMOVED. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT. THE PATIENT WAS RECEIVING ONYX EMBOLIZATION TO TREAT AN AVM IN THE INTRAMUSCULAR, PROXIMAL FEMUR "MUSCULUS VASTUS LATERALIS". VESSEL TORTUOSITY WAS SEVERE AND THE ACCESS VESSEL WAS THE FEMORAL. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED PER IFU AND THE CATHETER WAS FLUSHED AS DIRECTED. THERE WAS NO FRICTION OR DIFFICULTY DURING INJECTION AND THE CATHETER TIP BECAME ENTRAPPED/STUCK IN THE ONYX. THERE WAS APPROXIMATELY 1 CM OF REFLUX LOCATED ON THE MICROCATHETER AND THERE WAS VASOSPASM OBSERVED. AFTER THE CATHETER SEPARATED, THE SNARE COULD NOT SUCCESSFULLY REMOVE THE DEVICE AND AS A RESULT SURGERY WAS PERFORMED. THE SURGERY WAS ATHERECTOMY OF THE COMMON FEMORAL ARTERY (CFA) AND THE CATHETER WAS PULLED BACK OVER THE 6F SHEATH. APPROXIMATELY 6 CM OF THE CATHETER WAS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710922 APOLLO AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-5095-000 A395038

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R