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

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
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
Medtronic received information regarding a concerto coil that failed to detach.It was reported that the device was prepared and used according to the instructions for use (ifu).The coil did not detach with the instant detacher or manual attempts.The coil was removed and replaced to complete the procedure.There were no patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
Analysis of the concerto coil (lot no.B099609) found no damages or irregularities with the introducer sheath.Dried blood was found on the concerto device.The actuator interface was found securely attached to the coupler tube.There is no evidence of detachment attempts using an instant detacher at this location.The break indicator was found intact.There is no evidence of manual detachment at this location.The concerto pusher was found bent at ~74.4 cm and found bent within the introducer sheath at ~134.9 cm from the proximal end.The distal ~1.0 cm of the pusher was found kinked.The coin was found still against the lumen stop.Blood was found under the ptfe shrink tubing and within 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 damaged.The concerto implant coil failed to detach using an in-house instant detacher or by breaking the break indicator and retracting the release wire as the release wire was found stuck.Under magnification, the ptfe shrink tubing was removed, and the blood was dissolved.The release wire was retracted, and the release wire was still stuck.The release wire distal to the distalmost kink was retracted and the coin exited the lumen stop with no further issues and no resistance encountered.No other damages or anomalies were found with the returned device.Based on the customer report and device analysis, the customer report of "non-detachment" was confirmed.It is likely the cause of the non-detachments is the blood found within the lumen stop and under the ptfe shrink tubing causing the coin to become stuck within the lumen stop.The concerto coil also had damages (bent/kinked) on the pusher which contributed towards non-detachment even after the blood was dissolved.It is possible the pusher became bent/kinked when attempting to advance against resistance.Customer reported performing detachment attempts using an instant detacher and by manual methods, however, no evidence of detachment attempts was found at the actuator interface and the break indicator.The implant coils were found damaged.Possible causes are patient vessel tortuosity or advancing device against resistance.Method code updated to b01.Result code updated to (b)(4).Conclusion code updated.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: 11941072
• Report Number: 2029214-2021-00676
• Device Sequence Number: 19890256
• Product Code: KRD
• UDI-Device Identifier: 00847536033481
• UDI-Public: 00847536033481
• 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
• Report Date (Section B): 08/30/2021

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: 10/09/2023
• Device Model Number: NV-2-4-HELIX
• Device Catalogue Number: NV-2-4-HELIX
• Device Lot Number: B099609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Initial Date Received by Manufacturer: 05/28/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1