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

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.Linked mdrs: 2029214-2019-00639, 2029214-2019-00640, 2029214-2019-00641, 2029214-2019-00642, 2029214-2019-00643.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the coil did not detach from the microcatheter.However, after replacing the coil, the procedure was completed without issue.The anatomy was reported to have been normal.2 to 3 detach attempts were made the instant detacher and 2 to 3 detachments were made via the manual method.Issues occurred prior to the detachment attempts.No damage was noted on the removed pushwire.The devices were prepared and used per the ifu.Ancillary devices include a progreat microcatheter.
Additional Manufacturer Narrative
D10.Device available, return date - additional information g4.Date manufacturer received - additional information g7.Type of report - additional information h2.Follow-up type - additional information h3.Device evaluation, device returned - additional information h6.Evaluation codes - additional information, device evaluation h10.Additional manufacturer narrative - additional information, device evaluation the concerto coil (model: nv-2-4-helix lot: a516063) was returned for analysis.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.No damages and irregularities were found with the concerto pushwire.The concerto implant coil was found still attached to the pushwire but damaged and stretched within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock positioned on the proximal end.No damages or irregularities were 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.A mechanical detachment attempt was performed using an in-house instant detacher which was unsuccessful in detaching the implant coil.A manual detachment attempt was performed by breaking the break indicator and pulling back the release wire.This was also unsuccessful in detaching the implant coil as resistance was encountered with the release wire, causing the pushwire to bend/kink.Under microscope, the jacket was removed, and dried blood was observed inside the pushwire, preventing the release wire and coin from pulling back from the lumen stop.The concerto coil was soaked in enzyte within an ultrasonic cleaner to dissolve the dried blood and the release wire was pulled back with no issue, detaching the implant coil.The lumen stop was found to be visually acceptable and the retainer ring was found to be slightly ovalized.Based on the analysis performed, the concerto coil was confirmed to have non-detachment as the pushwire was returned with the implant coil still attached, however, the cause cannot 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.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8745700
• Report Number: 2029214-2019-00641
• Device Sequence Number: 2371961
• Product Code: KRD
• UDI-Device Identifier: 00847536013308
• UDI-Public: 00847536013308
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 08/28/2020
• Device Model Number: NV-2-4-HELIX
• Device Lot Number: A516063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 09/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1