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

Model Number	QC-2-8-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) 2022 (b)(4) (rep, for): medtronic received a report that the spring coil could not be detached after 3 times of normal detachment.It was unknown if the physician attempted to detach via another instant detacher or via a hypotube.The devices were prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.The patient was undergoing surgery for treatment of an unruptured aneurysm with a max diameter of 4mm and a 3mm neck diameter.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: as found condition: the axium coil was returned for analysis within a shipping box; within a plastic bio-pouch; and within a dispenser coil.Visual inspection/damage location details: the axium coil was returned without introducer sheath.The axium pushwire was found to be broken from proximal end.The actuator interface, positive load indicator and break indicator were found to be broken/missing and retained by release wire.The missing parts were not returned, and reason was not provided.The axium pushwire was appeared to be bent from ~22.5cm and ~29.8cm from proximal end.A break at this location is indicative that a manual detachment was attempted.As the actuator interface and coupler tube were not returned, any mechanical detachment attempts using an instant detacher cannot be confirmed.The axium implant coil appears to be still attached to the pusher, however, the implant coil was found damaged.Under the microscope, the coin was found to be located against the lumen stop, the shield coil was found to be present.No damage was found with the shield coil.No other anomalies were observed.¿ testing/analysis: due to its damaged condition the axium coil could not be used for detachment testing with an in-house id.¿ conclusion: based on the device analysis and reported information, the customer¿s report of ¿non-detachment¿ was confirmed as the axium implant coil was returned still attached to the pusher.In this event, the damages found with the pusher (bends) likely contributed to the event causing the implant coil to not detach.Damage to the implant coil and pusher can occur if the user advances the coil against resistance.However, the cause for the damage could not be determined.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.
Event or Problem Description
Additional information received reported that there were no issues prior to the coil non-detachment, and no pushwire damage was observed.
Additional Manufacturer Narrative
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 HELIX
• 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: 13510858
• Report Number: 2029214-2022-00202
• Device Sequence Number: 5299136
• Product Code: KRD
• UDI-Device Identifier: 00847536029491
• UDI-Public: 00847536029491
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2022

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: 08/22/2024
• Device Model Number: QC-2-8-HELIX
• Device Catalogue Number: QC-2-8-HELIX
• Device Lot Number: B254397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 02/14/2022; 04/10/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/10/2022; 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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 Age: 69 YR
• Patient Sex: Male