AXIUM PRIME BRPL HLX
Report
- Report Number
- 9617601-2025-00553
- Event Type
- Malfunction
- Date Received
- June 18, 2025
- Date of Event
- June 15, 2025
- Report Date
- August 15, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- 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
CONTINUATION OF D10: PRODUCT ID 190-5091-150 (LOT: 0229906497); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID APB-2-4-3D-ES (LOT: 229115231); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID APB-1.5-3-3D-ES (LOT: 229655742); IMPLANT DATE N/A; EXPLANT DATE N/A. 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.
PRODUCT ANALYSIS: AS FOUND CONDITION: THE ECHELON-10 MICRO CATHETER AND TWO AXIUM PRIME DEVICES WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, WITHIN THREE INDIVIDUAL SEALED PLASTIC BIOHAZARD POUCHES, WITHIN THEIR OPENED INNER POUCHES AND WITHIN THEIR DISPENSER COILS. ONE AXIUM PRIME DEVICE WAS RETURNED FURTHER WITHIN AN INTRODUCER SHEATH. VISUAL INSPECTION/DAMAGE LOCATION DETAILS:THE DISTAL PUSHER WAS FOUND BENT AT ~0.5CM FROM THE DISTAL END. THE AXIUM PRIME IMPLANT COIL WAS FOUND BROKEN/SEPARATED FROM THE PUSHER AT THE DETACH ELEMENT WITH THE POLYPROPYLENE FILAMENT ALSO BROKEN. TESTING/ANALYSIS: THE RETURNED COIL COULD NOT BE USED FOR RESISTANCE TESTING DUE TO THE DAMAGES. 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 THE AXIUM COILS STUCK/RESISTANCE OCCURRED IN THE MIDDLE OF THE ECHELON CATHETER. THE CATHETER WAS DAMAGED AT UNKNOWN LOCATION, AND THE COILS WAS DAMAGED AT PUSHWIRE MIDDLE SEGMENT. THE PATIENT WAS UNDERGOING TREATMENT OF A SACCULAR, RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 1.5 MM 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 8MM DIAMETER. IT WAS REPORTED THAT AFTER POSITIONING THE INTERMEDIATE CATHETER, THE ECHLENON10 MICROCATHETER (BATCH: 0229906497) WAS ADVANCED TO THE LESION SITE. THE FIRST COIL, APB-2-4-3D-ES (BATCH: 229115231), WAS SELECTED, AND THE SURGEON REPORTED SLIGHT RESISTANCE DURING DELIVERY BUT SUCCESSFULLY DEPLOYED AND DETACHED THE COIL. FLUID INFUSION WAS CHECKED AND FOUND TO BE FUNCTIONING NORMALLY. THE SECOND COIL, APB-1.5-3-3D-ES (BATCH: 229655742), ENCOUNTERED SIGNIFICANT RESISTANCE NEAR THE PROXIMAL END OF THE MICROCATHETER DURING DELIVERY. THE COIL'S PUSHER WIRE BECAME BENT, LEADING THE SURGEON TO SUSPECT A COIL QUALITY ISSUE. SINCE THE SAME MODEL WAS UNAVAILABLE, APB-1-1-HX-ES WAS SELECTED AS A REPLACEMENT. HOWEVER, DURING DELIVERY, HIGH RESISTANCE WAS AGAIN OBSERVED, AND UPON ATTEMPTING TO RETRIEVE THE COIL, IT STRETCHED INSIDE THE MICROCATHETER. THE SURGEON WAS UNABLE TO DETERMINE WHETHER THE ISSUE WAS WITH THE MICROCATHETER OR THE COIL. ULTIMATELY, A MICROCATHETER AND COILS FROM ANOTHER MANUFACTURER WERE USED, ALLOWING THE SUCCESSFUL DELIVERY AND DETACHMENT OF TWO COILS. THE PATIENT EXPERIENCED NO COMPLICATIONS, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. BOTH THE MICROCATHETER AND THE TWO COILS WERE SUBMITTED FOR COMPLAINT PROCESSING. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE CATHETER RESISTANCE WAS NOT DETERMINED. REGARDING THE CAUSE OF THE THREE USED COILS RESISTANCE AND CATHETER DAMAGE, THE SURGEON CONSIDERED IT TO BE A PROBLEM WITH THE QUALITY OF THE MICROCATHETER. THE COIL DAMAGE MAY HAVE BEEN CAUSED BY THE RESISTANCE OF THE MICROCATHETER DURING DELIVERY. THE CATHETER DAMAGE OBSERVED WAS KINKING. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE COIL DAMAGE OBSERVED WAS A BREAKAGE. THE COIL APB-1-1-HX-ES, LOT # 229175967 WAS ACCURATE.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE CATHETER RESISTANCE WAS NOT DETERMINED. REGARDING THE CAUSE OF THE THREE USED COILS RESISTANCE AND CATHETER DAMAGE, THE SURGEON CONSIDERED IT TO BE A PROBLEM WITH THE QUALITY OF THE MICROCATHETER. THE COIL DAMAGE MAY HAVE BEEN CAUSED BY THE RESISTANCE OF THE MICROCATHETER DURING DELIVERY. THE CATHETER DAMAGE OBSERVED WAS KINKING. THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. THE COIL DAMAGE OBSERVED WAS A BREAKAGE. THE COIL APB-1-1-HX-ES, LOT # 229175967 WAS ACCURATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 747366 | AXIUM PRIME BRPL HLX | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION | KRD | MICRO THERAPEUTICS, INC. DBA EV3 | APB-1-1-HX-ES | 229175967 | 00763000313784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female |