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

Model Number	NV-2-6-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Medtronic received a report that the coils would not deploy with the instant detacher (id).Other coils deployed with the same detacher.The catheter was not the issue.2 attempts were made with the id, the physician did not try another id and did not try a manual attempt.There were no issues with the id.  the patient was undergoing surgery for treatment of a gi bleed.It was noted the patient's blood flow was normal and vessel tortuosity was normal.
Additional Manufacturer Narrative
H3: product analysis #(b)(4): equipment used- video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5), instant detacher (model: id-1-5 lot: 9443624) drawing(s) referenced: n/a as found condition- the concerto coil device was returned for analysis within a shipping box, within a resealable plastic biohazard pouch; within an opened concerto inner pouch and within an introducer sheath.A second concerto coil was also returned and will be assessed in pli-20.Visual inspection/damage location details - the actuator interface was found to be securely attached to the coupler tube.There was no evidence of detachment attempts using an instant detacher at this location.The break indicator was found intact.There were no evidence of manual detachment attempts at this location.The concerto pusher was found to be intact with no damages found.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 and partially extending out of the introducer sheath.Th implant coil was found damaged.Testing/analysis - an in-house instant detacher was used to attempt to detach the returned concerto coil.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 (which is normal).The implant coil was successfully detached on the first attempt without any difficulty.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, however, the cause could not be determined, and the failure could not be replicated as the device detached successfully during in-house testing.The customer reported no issues detaching other coils with the same instant detacher.The implant coil was found damaged.Possible causes are patient vessel tortuosity or advancing the device against resistance.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.(ngod10 2022-10-07) 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 reported that there were no issues with the coils or detacher.No pushwire damage reported or seen.

• 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: 15412140
• Report Number: 2029214-2022-01547
• Device Sequence Number: 6924907
• Product Code: KRD
• UDI-Device Identifier: 00847536033498
• UDI-Public: 00847536033498
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022

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: 04/14/2024
• Device Model Number: NV-2-6-HELIX
• Device Catalogue Number: NV-2-6-HELIX
• Device Lot Number: B191010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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 Age: 69 YR
• Patient Sex: Male