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

Model Number	NV-2-8-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2019
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.Linked with mdr: 2029214-2019-00453, 2029214-2019-00454.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that 2 concerto coils failed to detach with the instant detacher (id).The concerto coil failed to detach.3 to 4 detachment attempts were made with the instant detacher (id).It was asked if a 2nd id was used and if manual detachment was attempted, but this information was unknown.The id was discarded at the site.There were no issues with id.This event was reported to have occurred a second time with a replacement concerto coil.The reported devices and the accessory devices were prepared as indicated in the instructions for use (ifu).The customer was notified that the devices should be returned for analysis.The patient was being treated for an unruptured, saccular, extracranial artery aneurysm with a max diameter of 3.5mm, and a neck diameter of 1.2mm.The blood flow and the anatomy were reported to have been normal.No patient injury occurred.
Additional Manufacturer Narrative
H3: there is no evidence of either manual or mechanical detach attempts as there was no damage to the actuator interface, tack weld/twr crimp, positive load indicator, coupler tube and break indicator.Kinks and bends were found along the length of the pusher between ~21.2cm to ~150.8cm from the proximal end.The coin was found to be present but jammed within the lumen stop; with the shield coil present and undamaged.Mechanical detachment was attempted using an in-house instant detacher, however, the implant coil failed to detach.Manual detachment was then attempted by breaking the break indicator which also failed to detach the implant coil.The release wire was pulled back, but resistance was encountered, and the coin failed to exit the lumen stop.A second attempt at manual detachment was performed by breaking the pusher distal to the most distal kink at ~150.8cm.The coin again failed to withdraw and release the detach element.Under microscope, the outer jacket was removed to g ain access to the coin.The coin was successfully pulled out of the lumen stop using tweezers against resistance.No damage was found to the coin.The coin was measured in 3 locations and was found to be within specifications.Measured 0.083mm @ 0.063mm; measured 0.089mm @ 0.127mm; measured 0.091mm @ 0.275mm.The lumen stop and the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00276¿ and found to be within (0.00220" minimum - 0.0029" maximum).The retainer ring inner diameter (id) was measured to be 0.00450¿and found to be within (0.00455"+/- 0.00010").No other anomalies were observed.Based on the analysis performed, the concerto coil was confirmed to have non-detachment as the pusher was returned with the implant coil still attached.Based on the returned device, the pusher was found bent and kinked along its length, indicative of either high tortuosity or damage during return shipping to medtronic for analysis.The non-detach was determined to be caused when the coin became lodged within the lumen stop, however, the cause of the stuck coin could not be determined.There was no 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.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: 8604172
• Report Number: 2029214-2019-00453
• Device Sequence Number: 3236069
• Product Code: KRD
• UDI-Device Identifier: 00847536013346
• UDI-Public: 00847536013346
• 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): 07/25/2019

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: 08/28/2021
• Device Model Number: NV-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: A699776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1