AXIUM PRIME BARE PL 3D
Report
- Report Number
- 9617601-2025-01898
- Event Type
- Malfunction
- Date Received
- October 9, 2025
- Date of Event
- October 6, 2025
- Report Date
- December 15, 2025
- Manufacturer
- MEDTRONIC MEXICO S. DE R.L. DE CV
- Product Code
- KRD
- PMA / PMN Number
- K151447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: AXIUM COIL PRODUCT ID APB-2-4-HX-ES (LOT: 230574114); PRODUCT TYPE: ; IMPLANT DATE N/A; EXPLANT DATE N/A; ECHELON 10 MICROCATHETER PRODUCT ID: 145-5091-150 (LOT: D040408); PRODUCT TYPE: 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 (CONDITION OF RETURNED DEVICE): TWO AXIUM PRIME COILS AND AN ECHELON-10 MICRO CATHETER WERE RETURNED WITHIN A SHIPPING BOX; WITHIN THEIR OPENED AXIUM PRIME COIL OUTER CARTONS; WITHIN THEIR OPENED AXIUM PRIME COIL INNER POUCHES AND WITHIN INDIVIDUAL DISPENSER TRACKS. THE AXIUM PRIME COILS WERE RETURNED WITHIN THEIR INTRODUCER SHEATHS. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: (PLI-10) NO BENDS OR KINKS WERE FOUND WITH THE AXIUM IMPLANT COIL PUSHWIRE. THE AXIUM PRIME COIL WAS FOUND TO BE STRETCHED AND DAMAGED WITHIN. THE AXIUM PRIME COIL WAS UNABLE TO BE PUSHED OUT FURTHER FROM INTRODUCER SHEATH FOR ANALYSIS AS IT WAS FOUND TO BE STUCK. NO OTHER ANOMALIES WERE OBSERVED. (PLI-20) THE ACTUATOR INTERFACE, POSITIVE LOAD INDICATOR AND COUPLER TUBE WERE FOUND TO BE INTACT. THIS IS INDICATIVE MECHANICAL METHOD DETACHMENT WAS NOT ATTEMPTED. THE AXIUM PRIME COIL PUSHWIRE WAS FOUND TO BE BENT AT ~45.8CM AND AT ~62.4CM FROM PROXIMAL END. THE AXIUM PRIME COIL WAS FOUND TO BE STILL ATTACHED. THE AXIUM PRIME COIL WAS FOUND TO BE STRETCHED WITHIN INTRODUCER SHEATH. THE AXIUM PRIME COIL WAS PUSHED OUT FURTHER FROM INTRODUCER SHEATH FOR ADDITIONAL ANALYSIS. THE AXIUM IMPLANT COIL WAS FOUND TO BE STRETCHED AND DAMAGED. NO OTHER ANOMALIES WERE OBSERVED. (PLI-30) THE ECHELON-10 TOTAL LENGTH WAS MEASURED TO BE ~155.3CM. THE ECHELON-10 USABLE LENGTH WAS MEASURED TO BE ~147.5CM WHICH IS WITHIN SPECIFICATION. UPON VISUAL EXAMINATION, NO ISSUES WERE FOUND WITH THE ECHELON-10 HUB. THE CATHETER BODY WAS FOUND TO BE KINKED AT ~146.6CM AND AT ~141.4CM FROM DISTAL TIP. NO DAMAGES WERE FOUND WITH THE DISTAL TIP. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): (PLI-10) THE AXIUM IMPLANT COIL TIP OD (OUTER DIAMETER) WAS MEASURED TO BE 0.0109¿ WHICH IS WITHIN SPECIFICATIONS. THE ID (INNER DIAMETER) OF THE INTRODUCER SHEATH WAS MEASURED TO BE 0.0185¿ WHICH IS WITHIN SPECIFICATIONS. THE AXIUM IMPLANT COIL COULD NOT BE USED FOR RESISTANCE TESTING WITH RETURNED ECHELON-10 MICRO CATHETER DUE TO ITS DAMAGED CONDITION. (PLI-20) THE AXIUM IMPLANT COIL COULD NOT BE USED FOR RESISTANCE TESTING WITH RETURNED ECHELON-10 MICRO CATHETER DUE TO ITS DAMAGED CONDITION. (PLI-30) THE ECHELON-10 MICRO CATHETER WAS FLUSHED; WATER EXITED FROM DISTAL TIP. ONE IN-HOUSE AXIUM IMPLANT COIL WAS ABLE TO PASS THROUGH THE ECHELON-10 MICRO CATHETER HUB. HOWEVER, THE AXIUM IMPLANT COIL MET RESISTANCE AT CATHETER BODY KINK ~146.6CM FROM DISTAL TIP. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND THE REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL RESISTANCE/STUCK IN SHEATH¿ WAS CONFIRMED FOR PLI-10 AS THE AXIUM PRIME COIL WAS RETURNED STUCK WITHINT THE INTRODUCER SHEATH. IT IS POSSIBLE INSUFFICIENT PREPARATION OF THE AXIUM IMPLANT COIL, DAMAGE DURING PREPARATION OR IMPROPER HUBBING TECHNIQUE (OVER TIGHTENING OF THE RHV) COULD HAVE CONTRIBUTED TO THE EVENT. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THERE WAS NO INDICATION THAT THE EVENT WAS RELATED TO A POTENTIAL MANUFACTURING ISSUE, SO A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿COIL RESISTANCE/STUCK AT CATH HUB¿ WAS CONFIRMED FOR PLI-10/PLI-20; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED AS THE AXIUM PRIME COILS COULD NOT BE USED FOR RESISTANCE TESTING WITH RETURNED MICRO CATHETER DUE TO THEIR DAMAGED CONDITION. POSSIBLE CAUSES FOR COIL RESISTANCE AT CATHETER HUB ARE, BUT NOT LIMITED TO, FAILURE TO HYDRATE THE COIL PRIOR TO USE, FAILURE TO UTILIZE CONTINUOUS FLUSH, FAILURE TO USE A COMPATIBLE MICROCATHETER FOR DELIVERY, AND USE OF AN IMPROPER HUBBING TECHNIQUE (OVER TIGHTENING OF THE RHV/SHEATH FIRMLY SEATED INTO HUB). BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿PREMATURE DETACHMENT¿ COULD NOT BE CONFIRMED FOR PLI-20 AS THE COIL WAS FOUND TO BE STILL ATTACHED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER RESISTANCE DURING DEVICE DELIVERY¿ WAS CONFIRMED. IT IS LIKELY THE DAMAGE (KINKED) FOUND WITH THE RETURNED ECHELON-10 MICRO CATHETER THAT COULD HAVE CONTRIBUTED TO THE REPORTED RESISTANCE. POSSIBLE CONTRIBUTING FACTORS TO ¿CATHETER RESISTANCE DURING DEVICE DELIVERY¿ INCLUDE THE USE OF AN INCOMPATIBLE DEVICE, FAILURE TO PREPARE THE ANCILLARY DEVICES PRIOR TO USE, AND INSUFFICIENT CATHETER FLUSH. THE ROOT CAUSE COULD NOT BE DETERMINED. THE ECHELON-10 MICRO CATHETER HAS A LABELED ID (INNER DIAMETER) OF 0.017" WITH TWO SEPARATE MARKER BANDS. PER AXIUM PRIME COIL INSTRUCTIONS FOR USE (IFU): ¿AXIUM PRIME COILS SHOULD BE DELIVERED THROUGH A MICROCATHETER WITH A MINIMUM INSIDE DIAMETER OF 0.0165¿-0.017¿ WITH TWO MARKER BANDS. THEREFORE, THE ECHELON-10 MICRO CATHETER WAS FOUND TO BE COMPATIBLE FOR USE WITH THE AXIUM PRIME COILS AND CAN BE RULED OUT AS A POTENTIAL CAUSE. 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 WHILE PUSHING THE AXIUM PRIME BARE HX COIL IN THE ECHELON 10 MICROCATHETER HUB, RESISTANCE WAS MET AND THE COIL BECAME STUCK. THE IMPLANT COIL DID NOT PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH AT THE HUB, HOWEVER, IT DID PUSH SMOOTHLY OUT FROM THE INTRODUCER SHEATH AT THE PROXIMAL CATHETER. THE CATHETER AND COIL WERE NOT DAMAGED. WHILE PUSHING ANOTHER AXIUM PRIME BARE COIL IN THE ECHELON 10 MICROCATHETER HUB ,RESISTANCE WAS MET, THE COIL BECAME STUCK, AND THE COIL DETACHED WHEN IT WAS REMOVED. IT WAS ALSO NOTED THE DEVICE WAS STUCK OR RESISTANCE WAS MET IN THE PROXIMAL CATHETER. THE COIL PUSHED SMOOTHLY OUT FROM THE INTRODUCER SHEATH AND THERE WAS NO DAMAGE TO THE CATHETER OR COIL. BOTH COILS WERE REPLACED WITH MEDTRONIC COILS TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE PATIENT WAS UNDERGOING COIL EMBOLIZATION SURGERY FOR TREATMENT OF A RUPTURED, SACCULAR, POSTERIOR COMMUNICATING ARTERY ANEURYSM WITH A MAX DIAMETER OF 3.2 MM AND A 2.1 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS MINIMAL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU).
ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DETACHMENT ATTEMPTS (INSTANT DETACHER OR MANUAL METHOD) WERE MADE. NO KINK OR DAMAGE WAS OBSERVED ON THE PUSHWIRE. A TOTAL OF FOUR COILS WERE DEPLOYED: TWO COILS BEFORE RESISTANCE, ONE REPLACEMENT COIL AFTER THE ISSUE, AND ONE COIL AFTER THE SECOND COIL ISSUE. DURING PREPARATION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545645 | AXIUM PRIME BARE PL 3D | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION | KRD | MEDTRONIC MEXICO S. DE R.L. DE CV | APB-1.5-4-3D-ES | 229381271 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | SEE H11... |