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

Model Number	NV-10-30-HELIX
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/05/2021
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 a report that there was resistance felt during delivery and the coil was broken.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the subcarinal vascular location with an unknown max diameter and a 3mm neck diameter.It was noted the patient's blood flow was high and vessel tortuosity was severe.It was reported that the doctors found a piece of broken coil wire when they removed the introducer sheath from the femoral artery after completing the procedure.So they arranged the patient to do another ct scan and they found that the coil wire/filament was broken and retained in the patient.It was decided to cut down the groin and attempt to use a snare and remove the coil filament.After a few attempts, part of the coil filament was removed and broken into three pieces.There was a short segment of the coil filament that could not be removed and remained in the patient's body.The patient's condition was fine and there was no further treatment needed at the moment.It was thought that the coil filament was maybe due to a premature detachment of the coil during delivery.There was strong resistance felt during delivery and the coil prematurely deployed when the doctors attempted to remove the coil wire form the catheter.The coil was implanted in its intended location.The pushwire was bent/broken and not on purpose.The physician repositioned the coil 2-3 times.The physician did not attempt to detach the coil and the physician did not rotate the delivery pusher during the procedure.A continuous flush was administered during the procedure.The devices were prepared as indicated in the ifu.There were no patient symptoms or complications associated with this event.Ancillary devices include: merit model#7521-13 guide catheter and merit models28mc24130sn microcatheter.
Additional Manufacturer Narrative
H3: the actuator interface was found securely attached to the pusher.There is no evidence of detachment using an instant detacher was found at this location.The concerto pusher was found broken at the positive load indicator with the two segments retained by the release wire.The release wire was retracted out ~98.5cm.The break indicator was also found broken with the two segments retained by the release wire.The release wire was retracted out ~10.5cm.There are evidence of manual detachment attempts at these locations.The pusher was found bent at ~34.5cm and ~36.0cm from the distal end.The coin was found retracted out of the lumen stop.The shield coil was found intact with the implant coil already detached.The concerto implant coil was found stretched.The detach element was found undamaged.The coin, retainer ring and lumen stop were found undamaged.The concerto pusher was found broken at the positive load indicator and the break indicator, indicative that a manual detachment was attempted at this location.The release wire was found retracted and the coin was pulled out of the lumen stop, detaching the implant coil as intended by the detachment elements.As the merit 28mc24130sn micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the failures could not be determined.The 28mc24130sn micro catheter has a rated inner diameter of 0.020¿ (per merit website) is compatible for use with the concerto coil.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
• 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: 12915959
• Report Number: 2029214-2021-01551
• Device Sequence Number: 5143210
• Product Code: KRD
• UDI-Device Identifier: 00847536033610
• UDI-Public: 00847536033610
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2022

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: 06/30/2024
• Device Model Number: NV-10-30-HELIX
• Device Catalogue Number: NV-10-30-HELIX
• Device Lot Number: B229145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 01/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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: 65 YR
• Patient Sex: Male