MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR CONCERTO NYLON; DEVICE, EMBOLIZATION, VASCULAR

Model Number	NV-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	10/24/2018
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 report of concert coil non-detachment.The patient was undergoing treatment of an unruptured aneurysm.Vessel tortuosity was described as moderate.The devices were prepared as indicated in the ifu.It was reported that "while following the ifu, the physician hardly detach the coil on the target vessel (b/o resistance)".The coil was replaced with a new coil to continue the procedure without further issue.There were no reports of patient injury in association with this event.There are no images available for review.
Additional Manufacturer Narrative
The device was returned for evaluation within its introducer sheath; inside of a plastic bag and a shipping carton.The instant detacher was not returned; therefore, any contributing factors from the detacher could not be assessed.The tack weld replacement (twr) crimp and the pushwire distal to the break indicator (manual detachment location) were found to be intact.The pushwire found to be bent at 7.0 cm, 34.0 cm and 94.0 cm from the proximal end.The implant coil appeared to be in good condition.Under the microscope, the coin was located against the lumen stop.An in-house instant detacher was used to actuate the returned coil and the implant coil detached within 2 attempts, with difficulty due to the bends on the pushwire.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations and was found within specifications: specification dimensions for the coin are: @ 0.063mm: 0.063-0.089mm; @ 0.127mm: 0.075-0.105mm; @ 0.275mm: 0.086-0.108mm.Measured 0.073mm @ 0.063mm; measured 0.089mm @ 0.127mm; measured 0.090mm @ 0.275mm.The outer jacket was then removed.The i.D.Of the lumen stop and the retainer ring were found visually acceptable.The lumen stop inner diameter (id) was measured per dwgs31195 rev.A and found to be within specification.Specification dimension for the lumen stop inner fit id is 0.00220" minimum, and for the lumen stop inner fit id is 0.0029" maximum.It was measured 0.002687".The retainer ring inner diameter (id) was measured and found to be within specification.Specification dimension for the retainer ring inner dimension is 0.00455"+/- 0.00010 ".It was measured 0.00458".During evaluation, the detach element was removed from the implant coil.The detach element was in good shape and the detachment ball was found to be within specification = 0.0038" +/- 0.00010".The detachment ball was measured to be 0.00383".All other subassemblies appeared to be norm al and no other anomalies were observed.Based on the device analysis findings and the reported event details, the customer report of ¿non-detachment¿ was confirmed.The cause for the difficulty during detachment could not be determined; however, the intact twr crimps or the bends in the pushwire may have contributed to the non-detachment.The customer did not attempt to detach the implant coil by the manual method (via hypotube) as instructed per the ifu.The pushwire was found to be intact distal to the break indicator when the device was received.The returned coil performed as intended with an in-house instant detacher, with difficulty due to the bends on the pushwire.The cause for the bends could not be determined.All parts of the returned pushwire that could affect the detachment were found to be within specification.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. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8071080
• Report Number: 2029214-2018-00938
• Device Sequence Number: 2190105
• Product Code: KRD
• UDI-Device Identifier: 00847536013391
• UDI-Public: 00847536013391
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2019

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: 05/20/2021
• Device Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: A648425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 11/14/2018
• Supplement Report FDA Received Date: 02/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1