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

Model Number	NV-2-4-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the concerto coil was blocked (stuck) inside the microcatheter and it could not be deployed.The coil was replaced with another device to complete the procedure.It was noted that the coil was not damaged and had non-detachment.The number of attempts to detach the coil with the instant detacher was unknown and use of the manual method (breaking of the hypotube, an alternative detachment method presented in the instructions for use) was also unknown.The instant detacher was discarded.No patient injury was reported as a result of the event.Ancillary device: maestro merit microcatheter.
Additional Manufacturer Narrative
D10: device available for evaluation: additional information.G4.Date mfr rec: additional information.H2: type of follow up: device evaluation.H3: device evaluated by manufacturer: additional information.H6: codes updated the device was returned for evaluation and the clinical observation was confirmed.As received, the implant coil appeared to be still attached to the pushwire within the introducer sheath.The implant coil was found damaged in the introducer sheath.The instant detacher was not returned.The tack weld replacement (twr) crimps and the pushwire distal to the break indicator at the manual location (via hypotube) were found to be intact.No bends or kinks were found with the pushwire.Under the microscope, the coin was found to be located against the lumen stop, the shield coil was found to be present, and the implant coil was still attached to the pushwire.An in-house instant detacher was then selected for detachment testing and successfully detach the concerto coil on the first attempt without difficulty.The intact tack weld replacement (twr) crimps led to the failure of the implant coil to detach from the pushwire; however, the cause for the intact twr crimps could not be determined.The concerto implant coil was successfully detached from its pushwire with the use of an in-house instant detacher on the first attempt.The instant detacher was not returned; therefore, any contributing factors could not be assessed.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 HELIX COIL NYLON
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8785440
• Report Number: 2029214-2019-00736
• Device Sequence Number: 2038741
• Product Code: KRD
• UDI-Device Identifier: 00847536013308
• UDI-Public: 00847536013308
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

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: 10/08/2021
• Device Model Number: NV-2-4-HELIX
• Device Lot Number: A720942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1