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

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2018
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 a report that the coil pusher wire broke at the distal segment when attempting to deploy it into the patient.The patient was undergoing surgery for treatment of a "bleed." it was noted that a continuous flush was not used during the procedure.There were no related patient symptoms.
Event or Problem Description
The patient was ultimately treated with another coil.It was noted that the patient had a normal vessel anatomy.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The concerto coil¿s pusher was returned with no implant coil, sheath, microcatheter or other accessories.The proximal portion of the pusher appeared to be broken and separated with the release-wire extended out.The ai and positive load indicator were found to be missing from the pusher; it appeared the manual detachment method was performed in this location rather than the location specified in the instructions for use (ifu).The pusher was intact distal to the break indicator at the manual detachment location (via hypotube).The pusher was bent and kinked along its length, indicative of high tortuosity.The pusher was kinked at multiple locations.There had been no attempt to detach utilizing the manual method at the break indicator location.There was no implant at the distal end of the pusher, it had been detached and there were no pieces of the implant remaining.The shield coil was intact.The coin was pulled back way from the lumen stop.The outer jacket was removed around the area of the lumen stop so the id of the lumen stop could be measured.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be visually acceptable with no sign of damage.The lumen stop inner diameter (id) was measured and found to be within specification.The retainer ring inner diameter (id) was measured to be within specification.The coin was measured in 3 locations and was found to be within specifications.No other anomalies were observed.Based on the available evidence, the customer report of ¿pushwire broken¿ was confirmed.However, the pushwire broke at the proximal end instead of the distal end as indicated in the event descriptions.The proximal end of the pushwire broke and separate; along with the ai and the positive load indicator were missing from the pusher.It appeared the manual detachment method was performed in this location rather than the location specified in the ifu.The manual method, although performed in a location other than intended, did allow for retraction of the release wire and detachment of implant from the delivery system.There were no non-conformances to specification identified that could have contributed to the event.It is possible that the ¿lack of continuous flush with heparinized saline¿ may have contributed to the kinks on the pushwire.Per the concerto detachable coil and i.D.(instant detacher) instructions for use (ifu): directions for use: per our instruction for use (ifu): "gently immerse the concerto detachable coil and its detachment zone in heparinized saline.Take care not to stretch the coil during this procedure, in order to preserve the coil memory.While still immersed in the heparinized saline, point introducer sheath vertically into saline and gently retract the distal tip of the coil into the introducer sheath.In order to achieve optimal performance of the concerto detachable coil and to reduce the risk of thromboembolic complication, it is advised that a continuous saline flush be maintained between a) the femoral sheath and the guiding catheter, b) the micro catheter and guiding catheter and c) the micro catheter and the implant delivery pusher and the concerto detachable coil.Place the appropriate guiding catheter following recommended procedures.Connect a rotating hemostatic valve (rhv) to the hub of the guiding catheter.Attach a 3-way stopcock to the side arm of the rhv, then connect a line for the continuous flush.Attach a second rhv to the hub of the micro catheter.Attach a 1-way stopcock to the side arm of the rhv, then connect a line for continuous flush.For concerto detachable coils: one drop from the pressure bag every 3-5 seconds is suggested.For pgla or nylon microfilament concerto detachable coils: one drop from the pressure bag every 1-3 seconds is suggested.Check all fittings so that air is not introduced into guiding catheter or micro catheter during continuous flush.It is essential to confirm catheter compatibility with the conce rto detachable coil.The outer diameter of the concerto detachable coil should be checked to ensure that the coil will not block the catheter.Do not advance the coil with force if the coil becomes lodged within or outside the microcatheter.Determine the cause of resistance and remove the system when necessary.Insert the distal end of the introducer sheath through the rotating hemostatic valve (rhv) and into the hub of the microcatheter until the sheath is firmly seated.Tighten the rhv around the introducer sheath to prevent back flow of blood, but not so tight as to damage the coil during its introduction into the catheter.¿ precaution: "handle the concerto¿ detachable coil with care to avoid damage before or during treatment".Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 NEUROVA; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8152367
• Report Number: 2029214-2018-01053
• Device Sequence Number: 1770719
• Product Code: KRD
• UDI-Device Identifier: 00847536013308
• UDI-Public: 00847536013308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2019

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: 04/22/2021
• Device Model Number: NV-2-4-HELIX
• Device Catalogue Number: NV-2-4-HELIX
• Device Lot Number: A634523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/14/2018; 03/01/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/27/2018; 03/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1