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

Model Number	NV-3-4-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
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 the coil would not detach.The 3rd coil was placed into the aneurysm and advanced with no issues.It was noted that manual detachment was at the proper mark but the coil would not detach.A manual detachment was attempted via hypotube.There were no patient symptoms or complications associated with this event.The patient was being treated for an unruptured splenic aneurysm with a max diameter of 2.9 mm and a neck diameter 2.2 mm.The vessel tortuosity was severe with a normal blood flow.The patient suffered from sulfa and adhesive allergies, cirrhosis, gerd, asthma and hypertension.
Event or Problem Description
Medtronic received a report that the coil would not detach.The 3rd coil was placed into the aneurysm and advanced with no issues.It was noted that manual detachment was at the proper mark but the coil would not detach.A manual detachment was attempted via hypotube.There were no patient symptoms or complications associated with this event.The patient was being treated for an unruptured splenic aneurysm with a max diameter of 2.9 mm and a neck diameter 2.2 mm.The vessel tortuosity was severe with a normal blood flow.The patient suffered from sulfa and adhesive allergies, cirrhosis, gerd, asthma and hypertension.Additional information received reported there were no issues during the procedure prior to the non-detachment.There was no pushwire observed after removal from the patient.
Additional Manufacturer Narrative
Updated with additional information received.Coding updated based on information received and investigation.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: 12224828
• Report Number: 2029214-2021-00920
• Device Sequence Number: 11872382
• Product Code: KRD
• UDI-Device Identifier: 00847536033511
• UDI-Public: 00847536033511
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2021

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: 12/07/2023
• Device Model Number: NV-3-4-HELIX
• Device Catalogue Number: NV-3-4-HELIX
• Device Lot Number: B128835
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 07/26/2021
• Supplement Report FDA Received Date: 08/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR