AXIUM 3D
Report
- Report Number
- 9617601-2025-00733
- Event Type
- Malfunction
- Date Received
- July 29, 2025
- Date of Event
- July 15, 2025
- Report Date
- October 3, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRD
- UDI-DI
- 00847536037977
- PMA / PMN Number
- K081465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
H3. PRODUCT ANALYSIS: EQUIPMENT USED: VIS M-81805, 203CM RULER M-83360 AS FOUND CONDITION (CONDITION OF RETURNED DEVICE): THE AXIUM DEVICE WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, INSIDE OF A SEALED PLASTIC BIOHAZARD POUCH, AN OPENED INDIVIDUAL AXIUM INNER POUCH AND WITHIN AN INTRODUCER SHEATH. NO MICROCATHETER WAS RETURNED. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE INTRODUCER SHEATH WAS FOUND TO BE APPLIED INCORRECTLY WITH THE WAVELOCK FACING TOWARDS THE DISTAL END OF THE IMPLANT COIL. THE INTRODUCE SHEATH WAS FOUND TO BE IN GOOD CONDITION. THE PUSHWIRE WAS FOUND TO BE BENT AT ~50.8CM FROM THE PROXIMAL END; IN ADDITION, THE PUSHWIRE FOUND TO BE BENT WITHIN THE INTRODUCE SHEATH AT ~73.7CM AND BENT AT ~53.4CM FROM THE DISTAL END. THE AXIUM IMPLANT COIL WAS FOUND TO BE DAMAGED WITHIN THE INTRODUCER SHEATH (WAVELOCK); HOWEVER STILL INTACT WITH THE PUSHWIRE DETACH ELEMENT. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): DURING TESTING , THE AXIUM IMPLANT COIL WAS FLUSHED WITH WATER, AND RETRACTED FROM THE INTRODUCER SHEATH WITHOUT ANY ISSUES. THE AXIUM IMPLANT COIL WAS RESHEATH CORRECTLY, AGAINST SOME RESISTANCE. NO FURTHER RESISTANCE TESTING WAS PERFORMED. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND THE REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL RESISTANCE/STUCK IN CATHETER ¿ WAS UNABLE TO BE CONFIRMED; HOWEVER, THE EVENT COULD NOT BE RULED OUT. THE DAMAGE FOUND WITH THE AXIUM DEVICE WAS FOUND TO BE CONSISTENT WITH ADVANCEMENT AGAINST RESISTANCE. THE AXIUM DEVICE WAS RETURNED WITH THE PUSHWIRE BENT AND THE IMPLANT COIL DAMAGED WITHIN THE INTRODUCER SHEATH. THE INTRODUCER SHEATH WAS FOUND TO BE APPLIED INVERTED, WHICH COULD HAVE HAPPENED DURING PREPARATION. THE ECHELON-10 MICROCATHETER MENTIONED IN THE REPORT WAS NOT RETURNED; THEREFORE, ANY CONTRIBUTION THE MICROCATHETER HAD TOWARDS RESISTANCE WAS UNABLE TO BE ASSESSED. THE ECHELON-10 MICROCATHETER WAS FOUND TO BE COMPATIBLE WITH THE AXIUM DEVICE. A POSSIBLE CAUSED OF ¿COIL RESISTANCE/STUCK IN CATHETER¿ COULD HAVE BEEN CAUSED BY THE INVERTED INTRODUCER SHEATH. THE CORRECT POSITION OF THE INTRODUCER SHEATH IS WITH THE WAVELOCK FACING TOWARDS THE PROXIMAL END OF THE PUSHWIRE. THE INTRODUCER SHEATH WAVELOCK AROUND THE DISTAL END OF THE IMPLANT COIL , CAN POSSIBLY LEAD TO RESISTANCE WITHIN THE INTRODUCER SHEATH, OR WHILE ADVANCING THE AXIUM IMPLANT COIL WITHIN A MICROCATHETER; HOWEVER, THE ROOT CAUSE OF ¿ COIL RESISTANCE/STUCK IN CATHETER¿ WAS UNABLE TO BE DETERMINED. ANOTHER POSSIBLE CAUSE OF ¿ COIL RESISTANCE/STUCK IN CATHETER¿ COULD HAVE BEEN CAUSED BY DAMAGE OR KINK TO PUSHWIRE. BASED ON THE DEVICE ANALYSIS AND THE REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL SEPARATION/BREAK¿ WAS UNABLE TO BE CONFIRMED AS THE IMPLANT COIL WAS RETURNED STILL ATTACHED TO THE PUSHWIRE. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. BASED ON THE DEVICE ANALYSIS AND THE REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿RESISTANCE/FAILURE TO RESHEATH¿ WAS ABLE TO BE CONFIRMED. DURING TESTING THE AXIUM IMPLANT COIL WAS ABLE TO BE RESEARCHED WITH SOME MINOR RESISTANCE, WHICH WAS CAUSED BY THE DAMAGED PUSHWIRE. A POSSIBLE CAUSE FOR ¿ RESISTANCE/FAILURE TO RESHEATH¿ IS BUT NOT LIMITED TO FAILURE TO HYDRATE PER IFU OR SHEATH NOT HELD VERTICALLY DURING HYDRATION. THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU; IN ADDITION, A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). H6. CODING UPATED BASED ON ANALYSIS FINDINGS. 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.
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.
MEDTRONIC RECEIVED A REPORT THAT WHEN FIST COIL INSERTED INTO THE CATHETER, IT STUCK IN THE MIDDLE AND WHEN PULLED, IT WAS BROKEN. THE SECOND COIL WAS INSERTED INTO THE CATHETER, SAME PROBLEM HAPPENED. WHEN WE USE THE THIRD COIL (AXIUM 9X30 3D) IT WAS SUCCESSFUL. THE COILS WERE STUCK IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS NOT DAMAGED. THE COIL WAS DAMAGED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT NEUROVASCULAR ABNORMALITIES. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND V ESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A ECHELON (MEDTRONIC) 105-5091-150; AVIGO (MEDTRONIC) 103-0606-200 GUIDEWIRE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO DETACHMENTS ATTEMPTS WERE MADE. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE. THE COIL WAS REMOVED FROM THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1788221 | AXIUM 3D | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION | KRD | MICRO THERAPEUTICS, INC. DBA EV3 | QC-14-30-3D | 230025312 | 00847536037977 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Male |