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

Model Number	QC-3-8-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this coil would not detach with an instant detacher or using manual detachment method (breaking hypotube method; an alternative method presented in the instruction for use).The patient was undergoing embolization treatment for a small unruptured saccular left clinoid aneurysm, measuring 4mmx5.1mm it was reported that the microcatheter was placed in place to deliver the coil.After delivery, it was released.The replacement of the detacher failed to be released.Replaced other products.It was reported that the physician attempted to detach the coil two times with the instant detacher and one time with second detacher, but this coil did not detach.There were not any patient symptoms or complications associated with this event.No images available for review.No patient injury was reported.The patient¿s blood flow was normal.The vessel was observed moderately tortuous.Reported device and any accessory devices were prepared as indicated in the ifu.As a result of the issue the devices were replaced to complete the procedure.A manual detachment method was attempted, the coil was removed from the patient.Echelon 10, instant detacher was discarded synchro.
Additional Manufacturer Narrative
The axium coil was returned without a dispenser coil and within an introducer sheath.There was no instant detacher, microcatheter, or accessories returned with the device.The actuator interface was securely attached to the coupler tube.No damages or irregularity was observed with the actuator interface, positive load indicator, coupler tube, break indicator, and crimps.There are no indications of any mechanical or manual detachment attempts at these locations.The pushwire was found bent within the introducer sheath.The implant coil was found still attached to the pushwire but stretched and damaged within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock positioned on the proximal end.No damage was found with the introducer sheath.The coin was found to be present and pushed up against the lumen stop; with the shield coil present and intact.Dried blood was found within the pushwire jacket.An attempt to remove the jacket and pull back the release wire was unsuccessful.The release wire broken within the retainer ring hole due to resistance.The lumen stop was found to be visually acceptable.The lumen stop inner diameter (id) was measured and found to be within specification.Due to the release wire becoming stuck within the retainer ring, the retainer ring could not be measured or evaluated as the implant coil did not detach.No other anomalies were observed.Based on the analysis performed, the axium coil was confirmed to have non-detachment as the pushwire was returned with the implant coil still attached, however, the cause cannot be determined.There was no evidence that any mechanical detachment attempts using an instant detacher or manual detachment by breaking the break indicator were made.During analysis, the implant coil did not detach; however, further analysis could not be performed due to the release wire break.It is likely the dried blood within the pushwire caused resistance when the release wire was retracted leading to the break in the release wire.The pushwire was found bent along its length, indicative of either high tortuosity, advancing device against resistance or damage during return shipping to medtronic for analysis.The implant coil was found stretched and damaged within the introducer sheath; however, the cause could not be determined.Possible causes for coil stretching/damage are patient vessel tortuosity, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, and advancing/retracting device against resistance.There was no malfunction of the device or non-conformance to specification identified that led to the non-detachment.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the instant detacher was not returned, any contribution of the instant detacher to the non-detachment could not be determined.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.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
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8916341
• Report Number: 2029214-2019-00862
• Device Sequence Number: 1811881
• Product Code: KRD
• UDI-Device Identifier: 00847536017634
• UDI-Public: 00847536017634
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2019

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: 11/17/2020
• Device Model Number: QC-3-8-HELIX
• Device Catalogue Number: QC-3-8-HELIX
• Device Lot Number: A558399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 10/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR