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

Model Number NV-5-15-HELIX

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

Medtronic received a report that the coil did not detach with both methods.A new medtronic device was used to complete the procedure.The devices were prepared as indicated in the ifu.There were no patient symptoms or complications associated with the event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: the concerto coil was returned for analysis within a shipping box; within a plastic bio-pouch; and within a dispenser coil.There was no instant detacher returned with the device.Visual inspection/damage location details: the ai crimps and coupler tube were present and intact.The positive load indicator and break indicator were still intact.No evidence of mechanical or manual detachment attempt was found.The coin was present at the lumen stop.The implant coil was still attached to the pushwire.No damage was found with the shield coil.The lumen stop and the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00270¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00462¿and found to be within specification.No other anomalies were observed.Testing/analysis: an in-house instant detacher was used to test the returned concerto coil.No difficulty was experienced inserting the pushwire into the instant detacher, and the load indicator was not visible when the pushwire was fully seated in the instant detacher cap.The implant coil was successfully detached on the first attempt without any difficulty.Conclusion: based on the analysis performed, the customer report of ¿non-detach¿ was confirmed as the concerto coil was returned with the implant coil was still attached to the pushwire.However, the root cause could not be determined as the returned concerto coil was successfully detached on the first attempt using an-house instant detacher.In addition, no damages were found with the returned concerto coil.The customer reported that the coil did not detach with both methods.However, no evidence of either method was attempted.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.There was no non-conformance to specifications identified that lead to the non-detachment issue.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
• Type of Device: 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: 13015096
• MDR Text Key: 289746668
• Report Number: 2029214-2021-01621
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536033559
• UDI-Public: 00847536033559
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: NV-5-15-HELIX
• Device Catalogue Number: NV-5-15-HELIX
• Device Lot Number: B183591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1