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

Model Number	NV-7-30-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the concerto coil was stuck in the sheath.A loop was not made and the coil didn't advance. the coil was replaced, and the patient did not experience any injury or complications.The devices were prepared according to the instructions for use (ifu).The patient was undergoing treatment for an aneurysm.Ancillary devices include a progreat 2.4f microcatheter.Additional information received reported the cause of the event was not known.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
Product analysis: as found condition: the concerto pushwire was returned for analysis within a shipping box; within a plastic bio-pouch; and within a dispenser coil.There progreat 2.4f microcatheter used in this event was not returned for analysis.Visual inspection/damage location details: the concerto pushwire was returned without its introducer sheath.Therefore, any contributing factors from the introducer sheath could not be assessed.The actuator interface, coupler tube, and positive load indicator were found to be intact.However, the break indicator was found broken, and the release wire pulled back.The concerto pushwire was found to be bent at ~4.5cm and ~113.5cm from proximal end.The coin was present and against the lumen stop.The shield coil was intact, and the implant coil was already detached from pushwire and not returned for analysis.No other anomalies were observed.Testing/analysis: the concerto implant coil tip od (outer diameter) was unable to measured as the implant coil was detached and not returned.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations and were found to be within specifications.The lumen stop and retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) and retainer ring inner diameter (id) were measured to within specifications.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ could not be confirmed as the introducer sheath was not returned.However, the concerto coil was confirmed to have premature detachment as the concerto implant coil was detached from pushwire and not returned.The root cause could not be determined.Regarding the damage to the concerto pushwire, as the issue was not reported by the customer, it is possible the damage occurred during return to medtronic for evaluation.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: 15830418
• Report Number: 2029214-2022-01971
• Device Sequence Number: 5113868
• Product Code: KRD
• UDI-Device Identifier: 00847536033580
• UDI-Public: 00847536033580
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2022

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: 08/05/2024
• Device Model Number: NV-7-30-HELIX
• Device Catalogue Number: NV-7-30-HELIX
• Device Lot Number: B246310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/19/2022
• Date Device Manufactured: 08/06/2021
• 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 Sex: Unknown