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

Model Number	NV-8-30-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
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 information that a concerto coil did not detach.The devices were prepared according to the instructions for use (ifu).The coil did not detach from its wire (both manual and detacher methods were tried several times).A new medtronic device was used to complete the procedure.No symptoms were reported.
Additional Manufacturer Narrative
H3: product analysis #(b)(4): equipment used: vis (m-81805), 203cm ruler (m-83360).Drawing(s) referenced: none.As found condition: the concerto coil was returned for analysis within a shipping box and within a plastic bio-pouch.Visual inspection/damage location details: the concerto pusher actuator interface (ai) was found intact.The pusher was found kink at ~2.5cm from the proximal end.The pusher hypotube break indicator (hbi) was found intact.The pusher was found broken at ~8.6cm from the proximal end with the release wire pulled for ~1.6mm.The implant coil was within the introducer sheath.The implant coil was found detached from the pusher within the introducer sheath.The concerto coil was removed from within the introducer sheath for further analysis.The release wire coin was found pulled back from the lumen stop.The pusher shield coil was found intact.The shield coil was removed, the release wire distal tip was not found extending out from the distal end of the pusher.The shrink tubing was removed, the release wire accessed and removed/pulled out from the lumen stop.The release wire coin was found in good condition.The pusher lumen stop and retainer ring were found in good condition.The implant coil was found in good condition.The implant coil detach element was found in good condition.Testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s ¿non-detachment¿ report was confirmed.As the concerto pusher actuator interface was found intact this indicates that either a detachment attempt using the instant detacher (id) was not performed or the instant detacher did not perform as intended.The instant detacher (id) used in the event was not returned.Therefore, an analysis could not be performed, and any contributing factors could not be assessed.The pusher was found broken; however, the pusher was not broken at the correct location via the hypotube break indicator.It is possible the damage to the pusher (kink) and the manual detachment attempt at the incorrect location contributed to the event.However, the root cause for the non-detachment could not be confirmed.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, 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: 13945734
• Report Number: 2029214-2022-00519
• Device Sequence Number: 6431809
• Product Code: KRD
• UDI-Device Identifier: 00847536033597
• UDI-Public: 00847536033597
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• 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: 05/05/2024
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: B202073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2021
• 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