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

Model Number	NV-3-8-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
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
It was reported the coil was being used as per the ifu, but it could not be detached either instant detacher nor manual method.A new device was used to complete the procedure.There were no patient symptoms associated with the event.
Additional Manufacturer Narrative
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
Additional information received from a healthcare provider (hcp), via a manufacturing representative (rep), indicated the following were all unknown: how many detachment attempts were made via instant detacher, the number of detachment attempts via manual method, lot number of instant detacher, if there any issues prior to non-detachment, and if there was any damage observed to the device after removal.
Additional Manufacturer Narrative
Product analysis #267882387:testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.077mm @ 0.063mm; measured 0.086mm @ 0.127mm; measured 0.099mm @ 0.275mm) and found to be within specifications.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00279¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00462¿and found to be within specification.All other subassemblies appeared to be normal.No other anomalies were observed.Conclusion: based on the analysis performed, the concerto coil was not confirmed to have "non-detachment" issue as the pushwire was returned with the implant coil already detached.The root cause could not be determined.Based on the returned device, there was evidence of mechanical detachment attempt to detach the coil as the ai and coupler tubing were not intact.However, there was no manual detachment attempt to detach the coil as the break indicator was intact.The coin was not located at the lumen stop as it was pulling back.Pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.There was no non-conformance to specification identified that that led to the non-detachment issue.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the implant coil and instant detacher were not returned; any contribution of the implant coil and instant detacher to t he non-detachment issue could not be determined.Ls (b)(6) 2021.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.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
(b)(6) 2021 mpxr 830873 (for, hcp, rep): it was reported the coil was being used as per the ifu, but it could not be detached either instant detacher nor manual method.A new device was used to complete the procedure.There were no patient symptoms associated withthe event.(b)(6) 2021.E1 (hcp, rep, for): additional information received from a healthcare provider (hcp), via a manufacturing representative (rep), indicated the following were all unknown: how many detachment attempts were made via instant detacher, the number of detachment attempts via manual method, lot number of instant detacher, if there any issues prior to non-detachment, and if there was any damage observed to the device after removal.(b)(6) 2021.E2 (for, oth): no additional information received.(b)(6) 2021.E3 (oth, for): no additional information received.(b)(6) 2021.E4 (oth, for): no additional information received.

• 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
• MDR Report Key: 11769566
• Report Number: 2029214-2021-00525
• Device Sequence Number: 4244517
• Product Code: KRD
• UDI-Device Identifier: 00847536033528
• UDI-Public: 00847536033528
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2021

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: 03/17/2023
• Device Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: A993990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2021
• Supplement Date Received by Manufacturer: 05/05/2021; 08/10/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/26/2021; 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1