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.
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
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.
Additional Manufacturer Narrative
H3: the instant detacher and concerto coil were returned for analysis.During evaluation, a portion of the pusher (actuator interface) was found to be extending out from the instant detacher cap with the release wire broken from the pusher.An attempt was made to pull the actuator interface out from the instant detacher; however, the actuator interface was found to be stuck.The instant detacher was taken apart to evaluate the components.The actuator interface was found to not be stuck within the actuator.The actuator interface portion that was within the cap was found bent, preventing it from exiting the cap hole.The surface around the bottom inner diameter of the instant detacher cap appeared to be clean, but damaged (chipped).The returned concerto coil was found to still have the actuator interface securely attached to the coupler tube.The break indicator was found to still be intact.No evidence of de tachment attempts was found at these areas.The concerto pusher was found bent at ~69.2cm from the proximal end.The coin was found still within the lumen stop.Dried blood was found under the jacket and within the lumen stop.The implant coil was still attached to the pusher.The shield coil was found intact, and the implant coil was found damaged.The inner diameter of the cap hole was measured to be 0.0142¿, which is within specification (specification: 0.0145¿ ± 0.0010¿).The instant detacher was used to attempt to detach the returned concerto coil, which failed to detach the implant.The break indicator was broken, and the release wire was retracted.The release wire was found broken at ~176.2cm from the proximal end.No resistance was encountered prior to, during, or after the break.The ptfe shrink tubing was removed the distal release wire was retracted, however the coin did not exit the lumen stop as it was found stuck.The dried blood was dissolved; and the release wire was retracted, causing the coin to exit the lumen stop and releasing the implant coil with no resistance encountered.An in-house axium coil was then selected for testing with the instant detacher.No difficulty was experienced inserting the pusher into the instant detacher, and the load indicator was not visible when the pusher was fully seated in the instant detacher cap.The implant coil was successfully detached on the first attempt without any difficulty.Based on the device analysis, the customer report of ¿non-detachment¿ was confirmed.The concerto coil was returned with the implant coil still attached.The likely cause of the non-detachment is the dried blood found within the lumen stop and under the shrink tubing.When the blood was dissolved the coin was retracted out of the lumen stop with no issues.The release wire was found broken near the distal end.It is possible that the release wire broke when retracting against the resistance.However, no evidence of detachment attempts was found by manual method or by instant detacher.As the returned concerto coil still retained its actuator interface, it is unclear which device the actuator interface found within the instant detacher belongs to.The actuator interface was found bent within the cap, which would prevent the actuator interface from exiting the cap.The cause of the damage to the actuator interface could not be determined.It is possible the actuator interface became slightly bent prior to insertion into the instant detacher, causing the actuator interface to become bent further when it failed to enter the actuator.The instant detacher cap was found chipped, likely caused during the attempt to retract the actuator after it became stuck.The instant detacher successfully detached an in-house coil with no issues and is therefore, not a likely contributor towards the non-detachment.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
• MDR Report Key: 11769702
• Report Number: 2029214-2021-00528
• Device Sequence Number: 4244519
• 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): 08/19/2021

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: 09/17/2023
• Device Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: B088130
• 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; 08/12/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 05/26/2021; 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1