MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-1.5-2-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium prime coil could not be pushed out of the microcatheter. the coil was replaced, and the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for a ruptured, saccular aneurysm located in the m1 segment of the middle cerebral artery.The max diameter was 2mm, and the neck diameter was 1mm.The patient's blood flow and vessel tortuosity were normal.Additional information received reported that the resistance was in the middle of the echelon 10 microcatheter.The coil had pushed out of the introducer sheath smoothly, and there was no kink/damage observed to the coil.
Additional Manufacturer Narrative
Product analysis: as found condition: the axium prime coil was returned for analysis within a shipping box; within a sealed plastic pouch; and within a dispenser coil.The echelon-10 micro catheter used in the event was not returned.Therefore, device analysis could not be performed and conformance to specifications could not be determined.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017¿.Per the axium prime coil ifu (instructions for use): ¿axium prime detachable 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 compatible for use with the axium prime coil.Visual inspection/damage location details: the axium prime implant coil was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The axium prime pushwire was found to be broken at ~3.3cm from proximal end and retained by release wire.The axium prime implant coil was found to be damaged within the introducer sheath.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.Testing/analysis: due to its damaged condition, the axium prime coil could not be used for resistance testing with an in-house catheter.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed and the cause could not be determined.Advancing the axium prime coil against resistance would result in damage to the implant coil and pushwire.Possible contributing factors to ¿coil resistance¿ include the use of an incompatible device for delivery, tortuous anatomy, or failure to hydrate the axium prime coil prior to use.The echelon-10 micro catheter used in the event was not returned; therefore, any contributing factors (other than inner diameter specification) could not be assessed.The echelon-10 micro catheter was found to be compatible, the axium prime coil was prepared prior to use (which includes coil hydration), and the vessel tortuosity was normal.There was no non-conformance to specifications identified that led to the reported issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13447090
• Report Number: 2029214-2022-00154
• Device Sequence Number: 14727603
• Product Code: KRD
• UDI-Device Identifier: 00847536032125
• UDI-Public: 00847536032125
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2024
• Device Model Number: APB-1.5-2-HX-ES
• Device Catalogue Number: APB-1.5-2-HX-ES
• Device Lot Number: B154925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 02/03/2022
• Date Device Manufactured: 02/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female