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

Model Number	APB-3-10-HX-ES
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	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is reported at this time based on analysis results which indicated a reportable event.Product analysis: equipment used: video inspection system (m-78210), ruler 200cm (m-83361), camera (panasonic lumix dmc-zs5) as found condition: the axium implant coil was returned for analysis within a shipping box; within a plastic bio-pouch; within an opened axium prime inner pouch.The micro catheter used during the event will not be returned for analysis.In addition, the model or lot number were not provided; therefore, compatibility could not be assessed.Visual inspection/damage location details: the axium prime 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 bent within the introducer sheath at 69.5cm, 98.5cm and 132.5cm from distal end.The axium prime implant coil was found to be to be broken and not returned for analysis.Therefore, any contributing factors could not be assessed.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.Testing/analysis: the axium prime coil was not able to be pushed out from within the introducer sheath due to resistance.The axium prime coil could not be used for testing with an in-house microcatheter due to its damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/ stuck in catheter¿ could not be confirmed.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, severely tortuous patient anatomy, failure to hydrate the axium prime coil prior to use, damage/kink to pushwire and lack of continuous flush during delivery.The axium prime implant coil was found damaged and the pushwire was found bent.It is likely that the damage to the axium prime implant coil and pushwire occurred during the attempt to push the coil through the micro catheter against the reported resistance.The vessel tortuosity was moderate.Other possible causes for coil/pushwire damage are: lack of hydration before procedure, user does not maintain continuous flush.It was reported all devices were prepared as per the instructions for use (ifu.Since the micro catheter used in the event was not returned, any contribution of the micro catheter towards the ¿coil resistance/stuck in catheter¿ could not be assessed.As the model and lot number of the micro catheter was not reported, compatibility could not be assessed.However, the axium prime pushwire was confirmed to be kink and damaged as the axium prime pushwire was found to be bent at several locations.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.
Event or Problem Description
Medtronic received information that the coil had a large push resistance and could not be pushed in the microcatheter.Coil stuck in catheter.After the microcatheter was withdrawn, it was found that the push rod had a crease in the proximal segment.The patient was being treated for an unruptured saccular aneurysm with a max diameter of 5mm and a neck of 4mm.Vessel tortuosity was moderate.The devices were prepared as according to the instructions for use (ifu).  no symptoms were reported.Additional information received reported the resistance occurred in the middle and distal segments of the microcatheter.The coil pushed out of the introducer sheath smoothly.Information about the catheter was not known.
Additional Manufacturer Narrative
Section e corrected 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 13259352
• Report Number: 2029214-2022-00054
• Device Sequence Number: 4726967
• Product Code: KRD
• UDI-Device Identifier: 00847536032286
• UDI-Public: 00847536032286
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2022

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: 04/12/2024
• Device Model Number: APB-3-10-HX-ES
• Device Catalogue Number: APB-3-10-HX-ES
• Device Lot Number: B189458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Supplement Date Received by Manufacturer: 02/16/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/10/2022
• Date Device Manufactured: 04/13/2021
• 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: 86 YR
• Patient Sex: Female