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

Model Number NV-5-20-HELIX

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 07/23/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the concerto coil would not advance through the microcatheter and became stuck in the distal segment.When the coil was removed, it was evident that the coil had detached with all the pushing.No damage was observed to the coil or catheter.It was indicated that all devices were prepared as per the instructions for use (ifu), and there was no patient involvement with the event.Ancillary devices include a progreat, 0.027".

Manufacturer Narrative

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.

Event Description

Additional information received reporting that the patient was being treated for a splenic aneurysm, which is off-label use as the coil are approved for intracerebral use.There was no kink or damage observed to the pushwire after removal.Other concerto coils were used to successfully complete the procedure.

Manufacturer Narrative

Product analysis: equipment used: vis (m-77148), microscope, 203cm ruler (m-83360), camera (panasonic lumix dmc-zs5) the concerto coil (model: nv-5-20-helix lot: a913643) was returned for analysis.The non-medtronic micro catheter involved in the event was not returned for analysis.The concerto coil was decontaminated per manufacturer protocol.The actuator interface, positive load indicator, coupler tube, and break indicator were found to be intact.There is no evidence of any detachment attempts by mechanical or manual methods.The concerto pusher was found bent at ~19.5cm and ~60.1cm from the proximal end.The coin was present and against the lumen stop.The shield coil was found stretched.Dried blood was found on the shield coil.The detach element was found still attached to the pusher, however the detach element was found broken.The implant coil was returned already detached and found damaged.A manual detachment was attempted by breaking the break indicator and retracting the release wire.The detach element was detached with no issues on the first attempt.No other damages or anomalies were found.Based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ could not be confirmed.The returned concerto could not be use d for resistance testing due to its damaged condition.The implant coil was found damaged, shield coil was found stretched and the pusher was found bent.Potential causes for these failures are lack of hydration before procedure, user does not maintain continuous flush, tortuous anatomy, coils not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances the coil against resistance, and incompatible catheter.Customer indicated the device was prepared per ifu.The customer report of ¿premature detachment¿ was confirmed.The cause of the detachment is the break found on the detach element, causing the implant coil to separate from the pusher.There is no malfunction with the pusher that would contribute towards the premature detachment and in-house detachment attempt successfully detached the detach element as expected.Since the microcatheter used in the event was not returned, any contribution of the catheter to the issue could not be determined.The microcatheter has an inner diameter of 0.027¿ which is compatible for use with the concerto coil per ifu.Customer reported that the concerto coil was used off-label which could potentially contribute towards the resistance and premature detachment.There is no indication that the event is related to a potential manufacturing issue.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 NYLON
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10328380
• MDR Text Key: 200879293
• Report Number: 2029214-2020-00738
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536033566
• UDI-Public: 00847536033566
• Combination Product (y/n): N
• PMA/PMN Number: K090046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2022
• Device Model Number: NV-5-20-HELIX
• Device Catalogue Number: NV-5-20-HELIX
• Device Lot Number: A913643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 10/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1