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

Model Number	NV-5-15-HELIX
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Hematoma (1884); Convulsion/Seizure (4406); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2023
Type of Reportable Event	Death
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
Medtronic received information regarding 10 concerto coils that had compaction during the procedure.In the following weeks post-operative, the patient experienced unrelated subdural hematoma and died.It was reported that on (b)(6) 2023, the patient underwent a coil embolization procedure to treat a 1-2mm saccular pseudoaneurysm and hemorrhoids.It was noted that the 10 concerto coils were delivered, deployed, and detached successfully as intended.Coil compaction was observed but no reported impact to the patient at the time of the procedure.On (b)(6) 2023, the patient returned to the hospital and was noted to have an acute left subdural hematoma (sdh).The patient experienced several epileptic seizures and died, as a result, on (b)(6) 2023.The site assessment of the events concluded the events were not related to the procedure or the devices.The medtronic study sponsor assessment concluded the events were possibly related to the procedure but not related to the devices.However, the investigator conclusion agreed with the site assessment that the events were not related to the procedure or devices.Additional information received reported since this adverse event occurred 10 days post-index procedure, the sponsor will always consider that it is indeed possible that the adverse event could be related to the study index procedure due to the fact the adverse event occurred so close in time after the index procedure.During the hospital stay there were several epileptic seizures and as a result he died on (b)(6) 2023.Subdural hematoma was ¿acute¿.Concomitant medication was given due to the adverse event.The adverse event was treated with a surgical/open repair procedure.
Event or Problem Description
Additional information received reported patient got a drainage of the hematoma via an osteoplastic craniotomy - without complications on (b)(6) 2023.
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
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 during the hospital stay an intracranial bleeding was observed.Aneurysm embolization technique-1: front door.Traumatic bleed embolization technique-1: total vessel occlusion.
Event or Problem Description
Additional information received reported the medtronic sponsor assessment of the event was updated/corrected to indicate that the event of subdural hematoma and related outcome were not related to the procedure or the concerto coils.This event is no longer reportable.Mdr decision corrected to not reportable.No additional supplemental mdr's are required unless additional information received makes the event reportable.
Additional Manufacturer Narrative
Event related to regulatory reports: 2029214-2023-00953, 2029214-2023-00954, 2029214-2023-00955, 2029214-2023-00956, 2029214-2023-00957, 2029214-2023-00958, 2029214-2023-00959, 2029214-2023-00960, & 2029214-2023-00961.This event is no longer reportable.Mdr decision corrected to not reportable.No additional supplemental mdr's are required unless additional information received makes the event reportable.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.

• 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: 17175108
• Report Number: 2029214-2023-00952
• Device Sequence Number: 17014251
• Product Code: KRD
• UDI-Device Identifier: 00847536044937
• UDI-Public: 00847536044937
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/07/2025
• Device Model Number: NV-5-15-HELIX
• Device Catalogue Number: NV-5-15-HELIX
• Device Lot Number: 225631734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 06/28/2023; 06/30/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 06/30/2023; 06/30/2023; 07/10/2023
• Date Device Manufactured: 12/07/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 77 KG