MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-2.5-8-3D
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis #705519992:equipment used: vis m-78210; ruler 203cm m-83361; pin gauges m-84081; m-84082 document used: d00317007 rev.F; 50584doc1 rev.C as found condition: the axium coil was returned within a shipping box; within a sealed biohazard pouch; within an opened axium coil inner pouch and within a dispenser coil.Visual inspection/damage location details: the axium coil was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pusher with the wave-lock at the proximal end.The pusher was found to be broken with the release wire at ~ 7.9cm from the proximal end.No damages were found with the introducer sheath.The implant coil was found to be damaged within the introducer sheath.The implant coil could not be pushed out of the introducer sheath for further analysis.No anomalies were observed.Testing analysis: the introducer sheath id (inner diameter) was measured to be at 0.0185¿ (0.47mm) which was within specification (specification: 0.47mm +0.03 -0.00).The implant coil distal tip od (outer diameter) was measured to be at 0.0116¿ which was within specification (specification: 0.0112¿ +0.0010 -0.0020).The axium coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed.The axium coil was found damaged.In addition, the pusher was returned broken.The axium coil can become damaged if advanced against resistance.It is possible that these damages occurred when the customer attempted to advance the coil through the catheter against the resistance.Possible causes of resistance include the use of a damaged catheter, incompatible catheter, lack of hydration before the procedure, patient tortuous anatomy and lack of continuous flush with heparinized saline during delivery.The device was prepared according to the instructions for use (ifu).Information regarding a continuous flush was not provided.It is possible the patient¿s moderate vessel tortuosity contributed to the event.The echelon 10 microcatheter used for the event was not returned.Therefore, the condition of the echelon 10 microcatheter could not be assessed the echelon 10 microcatheter has a labeled id (inner diameter) of 0.017¿.As per the ifu, the axium coils are compatible for use with microcatheters with a minimum id (inner di ameter) of 0.0165¿.Therefore, the echelon 10 microcatheter was found to be compatible with the axium coils.The root cause could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.There were no reported issues preparing the axium coil prior to use (which includes coil hydration).Therefore, it is likely that the implant coil became damaged during preparation or due to an improper hubbing technique (over tightening of the rhv) causing resistance within the introducer sheath.Advancing the device against resistance likely caused the damages to the implant coil.However, the root cause for the resistance could not be determined.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.There were no reported issues preparing the axium coil prior to use (which includes coil hydration).Therefore, it is likely that the implant coil became damaged during preparation or due to an improper hubbing technique (over tightening of the rhv) causing resistance within the introducer sheath.Advancing the device against resistance likely caused the damages to the implant coil.In addition, it is also possible the presence of blood within the intr oducer sheath contributed to the resistance.However, the root cause for the resistance could not be determined.Based on the device analysis and reported information, the customer¿s ¿pusher kink/damage¿ report was confirmed.The pusher was returned kinked.Damages to the pusher can occur if the user advances the device against resistance.The cause for the damage could not be determined.(gamboj3 2023-05-05) 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.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.
Event or Problem Description
Medtronic received a report regarding axium coil resistance and echelon catheter resistance.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the left posterior communicating artery with a max diameter of 4.5  mm and a 3.3 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate. it was reported that when the axium coil was pushing in the echelon, the pushing guide rod got stuck and could not be pushed forward or retrieve, so the coil and microcatheter were removed.It was reported there was coil resistance/stuck in the distal section of the catheter.It is unknown if there was catheter damage.There was coil damage present on the pushwire distal segment.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a neuromax sheath, navien 6f guide catheter, echelon microcatheter, synchro 2 guidewire, and enterprise 4.5x22.Additional information received reported the coils did not push of the introducer sheath smoothly.

• Brand Name: AXIUM 3D
• 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: 16887760
• Report Number: 2029214-2023-00768
• Device Sequence Number: 20376950
• Product Code: KRD
• UDI-Device Identifier: 00847536037670
• UDI-Public: 00847536037670
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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: 05/27/2024
• Device Model Number: QC-2.5-8-3D
• Device Catalogue Number: QC-2.5-8-3D
• Device Lot Number: 222325696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown