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

Model Number NV-3-8-HELIX

Device Problems Incomplete or Missing Packaging (2312); Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2020

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 coil wasn't attached to the pushwire.The patient was undergoing surgery for a bleed.It was reported that the technician said they couldn't find the coil.It was believed the coil wasn't attached to the pushwire and was defective.The pushwire was advanced into the microcatheter, and they couldn't see the coil come out of the microcatheter.The detachment end was broken, and the could not be found in the microcatheter either.The same microcatheter was used for following coils to complete the procedure, and they went in successfully.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a progreat 2.4 microcatheter.

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 was received from manufacturer representative (rep) who reported to the physician clarified that the coil was, in fact, present during the case.The coil prematurely detached within the microcatheter after pulling back and readvancing.The coil and microcatheter were then removed together.Both devices were replaced and the coiling procedure was then able to be completed without further issue.It was reported that the patient's vessel anatomy was not tortuous.

Manufacturer Narrative

H3: the concerto pusher (model: nv-3-8-helix, lot: b060077) was returned for analysis.No damages or irregularities were found with the introducer sheath.The actuator interface was found securely attached to the coupler tube.No evidence of detachment using an instant detacher was found.The pusher was found to be broken at the break indicator (the manual detachment location); with the two segments retained by the release-wire.The coin was not against the lumen stop as it was fully retracted out.The shield coil was found broken.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations and was found to be within specifications.Measured 0.085mm @ 0.063mm; measured 0.096mm @ 0.127mm; measured 0.096mm @ 0.275mm.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00290¿ and found to be within specification (0.00220" minimum - 0.0029" maximum).The retainer ring inner diameter (id) was measured to be 0.00460¿and found to be within specification (0.00455"+/- 0.00010").The implant coil was already detached and not returned for analysis.No other anomalies were observed.Based on the analysis performed the concerto coil was confirmed to have detached.The pusher was found broken at the manual detachment location (break indicator) and the coin was pulled back from the lumen stop; causing the implant coil to detach as intended by the device.The cause of the pusher break could not be determined.Other possible causes for premature detachment are tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation or user advances coil against resistance.Customer reported all devices were prepared as per the ifu.There was no malfunction of the pusher or non-conformance to specification that may have contributed to the pre-mature detachment issues.As the implant coil and micro catheter were not returned for analysis, any contribution of the implant coil and micro catheter towards the premature detachment could not be determined.The progreat 2.4 micro catheter has an inner diameter of 0.022¿ (per terumois website) and is therefore compatible for use with the concerto coil.The shield coil was found broken.Potential causes are resistance during removal, patient vessel tortuosity, or catheter damage.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
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10488116
• MDR Text Key: 205521609
• Report Number: 2029214-2020-00885
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536033528
• UDI-Public: 00847536033528
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2023
• Device Model Number: NV-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: B060077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 87 YR