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 Codes	Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that a concerto coil would not detach.The deployment did not occur after the coil was placed in situ.The back end untwisted and cracked.The coil was still attached.Attempts to "re crack" were made to deploy the coil.
Additional Manufacturer Narrative
Product analysis: as found condition- the concerto was returned for analysis within a shipping box; within an opened concerto outer carton and within a tied-up plastic pouch.Visual inspection/damage location details ¿ the concerto pusher was found broken distal to the break indicator with the release wire broken.The proximal segment (actuator interface, positive load indicator, break indicator and coupler tube) was not returned for analysis.The concerto pusher was found kinked at ~16.0cm from the distal end.The coin was found present and still against 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 to be damaged.Testing/analysis ¿ the exposed release wire was pulled and found to be stuck within the pusher.The ptfe shrink tubing was removed distal to the kink and the release wire was retracted, detaching the implant coil with no issues and no additional resistance found within the pusher.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was confirmed as the device was returned with the implant coil still attached.The cause of the non-detachment was found to be the kinking found on the pusher, causing the release wire to not move freely within the pusher.It is possible the kinking occurred due to advancing against resistance.The release wire was found to move freely distal to the kinking, detaching the implant as expected.The release wire was found broken, likely due to the attempt to detach against the resistance within the pusher.The instant detacher used in the event was not returned.Therefore, any contribution of the instant detacher towards the non-detachment and conformance to specification could not be assessed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19042114
• Report Number: 2029214-2024-00573
• Device Sequence Number: 8472151
• Product Code: KRD
• UDI-Device Identifier: 00847536044975
• UDI-Public: 00847536044975
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 07/06/2026
• Device Model Number: NV-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: 226915340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2024
• Supplement Date Received by Manufacturer: 05/25/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown