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

Model Number	NV-2-8-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2022
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 concerto was not detached.The device was prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.Ancillary devices include: terumo progreat 2.4f microcatheter.
Additional Manufacturer Narrative
Product analysis #275744286:equipment used- video inspection system (m-78210), ruler (m-83361), camera (panasonic lumix dmc-zs5) drawing(s) referenced: n/a as found condition- the concerto was returned for analysis within a shipping box, within a sealed plastic biohazard pouch and partially within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was found securely attached to the coupler tube.There is no evidence of detachment attempts using an instant detacher at this location.The break indicator was found intact.There is no evidence of manual detachment at this location.The concerto pusher was found kinked at ~141.6cm from the proximal end.The distal segment of the pusher and implant coil was already deployed out of the introducer sheath.The coin was found still against the lumen stop.Blood was found under the ptfe shrink tubing and within the lumen stop.No damages or irregularities were found with the shield coil.The implant coil was found still attached to the pusher.The implant coil was found damaged.Testing/analysis ¿ the concerto implant coil failed to detach using an in-house instant detacher or by breaking the break indicator and retracting the release wire as the release wire was found stuck.Under magnification, the ptfe shrink tubing was removed, and the blood was dissolved.The release wire was retracted, and the coin exited the lumen stop with no issues and no resistance encountered.No other damages or anomalies were found with the returned device.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed.It is likely the cause of the non-detachment is the blood found within the lumen stop and under the ptfe shrink tubing causing the coin to become stuck within the lumen stop.The pusher was found bent.It is possible the pusher became bent when attempting to advance against resistance or damage during return shipping to medtronic.The implant coil was found damaged.It is possible the implant coil became damaged due to advancing against resistance or during handling/return shipping as the implant coil was returned already deployed out of its protective introducer sheath.(ngod10 2022-04-23) 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.
Event or Problem Description
2022-mar-11 mpxr 931089 (rep, for, dis): medtronic received a report that the concerto was not detached.The device was prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.Ancillary devices include: terumo progreat 2.4f microcatheter.2022-03-31 interface update (for, rep): additional information received reported that about 2 attempts were made to detach the coil using the instant detacher.Two attempts were made to detach the coil using the manual method.Prior to coil non-detachment there were no issues encountered.The pushwire was a little bent.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13973414
• Report Number: 2029214-2022-00546
• Device Sequence Number: 4676558
• Product Code: KRD
• UDI-Device Identifier: 00847536033504
• UDI-Public: 00847536033504
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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: 04/25/2024
• Device Model Number: NV-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: B196611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown