BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIUM PRIME BRPL HLX

    MDR report key: 17811041 · Received September 25, 2023

    Report

    Report Number
    9612164-2023-04342
    Event Type
    Malfunction
    Date Received
    September 25, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 25, 2023
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    KRD
    UDI-DI
    00763000313784
    PMA / PMN Number
    K151447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS # (B)(4) EQUIPMENT USED: VIS M-85519, 203CM RULER M-83361, AXIUM COIL (MODEL # QC-2-2-3D LOT #961924) DOCUMENT USED: DWGS105-5091-150 REV. BA AS FOUND CONDITION (CONDITION OF RETURNED DEVICE): THE AXIUM PRIME IMPLANT COIL AND ECHELON 10 MICRO CATHETER WERE BOTH RETURNED FOR ANALYSIS WITHIN SHIPPING BOX AND RETURNED WITHIN A SEALED PLASTIC BIOHAZARD POUCH. DAMAGE LOCATION DETAILS: THE AXIUM PRIME IMPLANT COIL WAS RETURNED WITHIN THE INTRODUCER SHEATH WHICH WAS FOUND TO BE APPLIED CORRECTLY WITH THE WAVELOCK FACING TOWARDS THE PROXIMAL END. THE INTRODUCER SHEATH WAS RETURNED IN GOOD CONDITION. THE PUSHWIRE WAS FOUND TO BE BENT WITHIN THE INTRODUCER SHEATH AT ~83.8CM, AT ~55.3CM AND AT ~8.1CM FROM THE DISTAL END. THE AXIUM PRIME PUSHER WAS NOT ABLE TO BE PUSHED OUT OF INTRODUCER SHEATH DUE TO RESISTANCE; THEREFORE, WAS PULLED OUT PROXIMALLY. THE IMPLANT COIL WAS FOUND TO HAVE BROKEN OFF FROM THE PUSHER FROM THE COIL SHELL WELD. IN ADDITION, THE IMPLANT COIL POLYPROPYLENE FILAMENT BROKE OFF FROM THE DETACH ELEMENT. THE IMPLANT COIL WAS NOT RETURNED. THE ECHELON 10 CATHETER WAS EXAMINED THE CATHETER HUB, CATHETER BODY AND DISTAL TIP WERE FOUND TO BE IN GOOD CONDITION. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): THE RETURNED AXIUM PRIME IMPLANT COIL COULD NOT BE USED FOR RESISTANCE TESTING DUE TO ITS DAMAGED CONDITIONS. THE TOTAL LENGTH OF THE ECHELON-10 WAS MEASURED TO BE ~155.4CM AND THE USABLE LENGTH WAS MEASURED TO BE ~147.7CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION 147.0 ±1.5CM). THE ECHELON-10 MICRO CATHETER WAS THEN FLUSHED WITH WATER. THE ECHELON -10 MICRO CATHETER WAS THEN TESTED WITH AN IN-HOUSE AXIUM COIL (MODEL # QC-2-2-3D, LOT #961924) WHICH ENTERED THE HUB AND EXITED DISTAL TIP WITHOUT ISSUES. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER REPORT OF ¿COIL STRETCHED¿ WAS CONFIRMED. POSSIBLE CAUSES FOR ¿COIL STRETCHED¿ ARE BUT NOT LIMITED TO ¿COIL IS NOT RETRACTED IN A ONE-TO ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING¿, ¿PUSHWIRE ROTATION¿ AND ¿USER ADVANCES THE COIL AGAINST RESISTANCE¿. IT WAS REPORTED THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. NO INFORMATION REGARDING COIL ROTATION WAS REPORTED. THE CUSTOMER REPORTED THAT THE PATIENT VESSEL TORTUOSITY AND BLOOD FLOW WERE BOTH NORMAL. THE AXIUM PRIME WAS RETURNED DAMAGED WITH THE COIL BROKEN OFF; THEREFORE, NO FURTHER ASSESSMENT COULD BE PROCESSED. LIKELY ADVANCING THE COIL AGAINST RESISTANCE CAN LEAD TO COIL STRETCHED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER REPORT OF ¿COIL RESISTANCE¿ WAS CONFIRMED. DAMAGED TO THE AXIUM PRIME COIL (BENT PUSHER, IMPLANT COIL BREAK) CAN BE CAUSED BY ADVANCING AGAINST RESISTANCE. POTENTIAL CAUSES ARE BUT NOT LIMITED TO INCOMPATIBLE CATHETER, LACK OF HYDRATION BEFORE PROCEDURE, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, TORTUOSITY ANATOMY AND DAMAGE OR KINK TO PUSHWIRE. AS THE AXIUM PRIME WAS RETURNED DAMAGED FOR ANALYSIS, ANY CONTRIBUTION OF THE AXIUM PRIME COIL TOWARDS THE RESISTANCE COULD NOT BE DETERMINED (ONLY COMPATIBILITY WAS ABLE TO BE DETERMINED). THE AXIUM PRIME (MODEL# APB-1-1-HX-ES AND LOT #225706400) WAS FOUND TO BE COMPATIBLE WITH THE ECHELON 10. THE ECHELON 10 CATHETER APPEARED TO BE COMPATIBLE FOR USE WITH THE AXIUM PRIME COIL AS IT HAS A LABELED INNER DIAMETER (ID) OF 0.0165¿- 0.017¿ WITH TWO BAND MARKERS. THE CUSTOMER REPORTED THAT CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. IT WAS ALSO NOTED THAT THE PATIENT VESSEL TORTUOSITY AND BLOOD FLOW WAS NORMAL. THE CUSTOMER ALSO REPORTED THAT ALL DEVICES WERE PREPARED PER IFU. THE AXIUM PRIME PUSHWIRE WAS FOUND TO BE BENT WITHIN THE INTRODUCER SHEATH WHICH CAN LEAD TO RESISTANCE, THEREFORE THE CAUSE FOR RESISTANCE WAS ABLE TO BE DETERMINED. 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

    MEDTRONIC RECEIVED A REPORT THAT THE COIL TIP WAS STRETCHED IN THE MICROCATHETER AND COULDN'T BE PUSHED OUT OR REMOVED. CATHETER RESISTANCE OCCURRED IN THE DISTAL SECTION. CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE DAMAGED LOCATION WAS ON THE IMPLANT COIL. THE PHYSICIAN DID NOT REPOSITION THE COIL DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED 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, UNRUPTURED ANEURYSM OF THE RIGHT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 5MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS NORMAL.  THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 9MM. ANCILLARY DEVICES INCLUDE AN ECHELON 105-5091-150  B342206 MICROCATHETER AND A GUIDE CATHETER. ADDITIONAL INFORMATION WAS RECEIVED THAT THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THERE WAS NO KINK/DAMAGE OBSERVED TO THE COIL AFTER REMOVAL AND NO ISSUES THAT RESULTED IN THE DAMAGE THAT WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881045 AXIUM PRIME BRPL HLX DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION KRD MEDTRONIC MEXICO APB-1-1-HX-ES 225706400 00763000313784

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female