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

Model Number	NV-3-8-HELIX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium prime coil was already detached from its wire when it was first opened. 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).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H3: as found condition: the concerto coil was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The pusher was returned within a dispenser coil and the already detached implant coil was returned within an introducer sheath.Visual inspection/damage location details: the actuator interface was found still securely attached to the coupler tube and the break indicator was found intact.No evidence of detachment attempts was found at these locations.The coin was found still against the lumen stop.The shield coil was found undamaged.The detach element was found still attached to the pusher.The concerto implant coil was broken from the detach element and was found within the introducer sheath.The implant coil was found damaged and stretched with the polypropylene filament also broken.No damages or irregularities were found with the introducer sheath.Liquid saline was found within the introducer sheath.No other anomalies were observed.Testing/analysis: n/a conclusion: based on the device analysis and reported information, the customer¿s report of ¿premature detachment¿ was confirmed.The cause of the detachment is the break of the implant coil from the detach element, however, the cause of the break could not be determined.It is possible that the implant coil became stuck within the introducer sheath and the implant coil became damaged/stretched/broken when the pusher was retracted out against the resistance.Saline was found within the introducer sheath, indicative that the sheath was flushed with saline during preparation, as opposed to advancing the implant coil out of the introducer sheath to hydrate.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the formal investigation, it is possible the damage occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.Therefore, the root cause could not be determined.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: 14090519
• Report Number: 2029214-2022-00617
• Device Sequence Number: 14679419
• Product Code: KRD
• UDI-Device Identifier: 00847536033528
• UDI-Public: 00847536033528
• 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,Followup
• Report Date (Section B): 06/06/2022

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: 08/24/2024
• Device Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: B255272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2021
• 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