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

Model Number	NV-2-8-HELIX
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The concerto coil has not been returned for evaluation.The device was not returned; the reported event could not be confirmed.The cause of the event could not be determined from the provided information.E.The physician who reported the event was not provided.The medtronic employee who became aware of the event is in section.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the implant coil showed some difficulty progressing in the catheter and eventually released inside the catheter.The pushwire reportedly had not been rotated during delivery of the coil.In addition, the pushwire was not observed to be bent or broken.The physician removed the device and replaced it with another device.The procedure was completed without any further problems.No injury to the patient was reported as a result of the event.The coil had been prepared as indicated in the instructions for use.
Additional Manufacturer Narrative
Received additional information that this event was received from the distributor (b)(4).No additional contact information was provided.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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
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 could not be confirmed about implant coil prematurely detached.As received, the concerto implant coil found to be broken within introducer sheath.The concerto coil pushwire was found to kinked and bent.The detach element was found to be intact.Under the microscope, the implant was found to be stretched and damaged within introducer sheath.It is likely that the pushwire and coil were damaged subsequently breaking the coil during the attempt to pull the coil back through the micro catheter against the reported resistance.Based on the device analysis and reported information, we were unable to determined the cause of the event.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 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: 8341493
• Report Number: 2029214-2019-00117
• Device Sequence Number: 11209974
• Product Code: KRD
• UDI-Device Identifier: 00847536013346
• UDI-Public: 00847536013346
• Combination Product (Y/N): N
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/23/2019

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: 10/03/2020
• Device Model Number: NV-2-8-HELIX
• Device Lot Number: A534253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2019
• Supplement Date Received by Manufacturer: 01/23/2019; 08/05/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 02/25/2019; 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1