MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number 145-5091-150

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/11/2023

Event Type  Injury  

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

Medtronic received a report that the echelon microcatheter broke and part remains in the patient.The patient was undergoing surgery for treatment of a right internal carotid artery c6 segment aneurysm.It was noted the patient's vessel tortuosity was moderate.The access vessel was the femoral artery with 7.6mm diameter.It was reported that the patient underwent stent-assisted aneurysm embolization for wide-necked aneurysm of the right internal carotid artery ophthalmic artery segment.A routine access was established, and a headway21 stent catheter was pre-set at the distal end of the lesion.Echelon10 entered the tumor cavity.After the livs stent was half-deployed, the coil was filled to achieve a dense embolization.After the stent was deployed and the coil and microcatheter echelon10 were withdrawn, it was found that the livs stent was not ideally attached to wall at the clinoid segment.So it was given a massage with a micro-guidewire, but the effect was not good.The echelon10 micro-catheter was then used to go up and down to massage under the guidance of the guidewire.Due to the angulation of blood vessel, the guidewire and microcatheter system entered under the stent, and the adjustment was fruitless.Withdrew the guidewire and microcatheter system, and found a mark point under the stent developed under fluoroscopy.After checking the echelon10 withdrawn from the body, it was found that the distal end of the microcatheter was broken and the distal mark fell off.Catheter separation/break occurred during use.There was no friction or difficulty during injection.Force was applied during delivery/removal.The catheter tip was entrapped/stuck.There was no vasospasm.The catheter was not stuck inside the guide catheter.There was no surgical or medicinal intervention required.The broken segments remain in the patient under the livs stent in the c5 segment of the right internal carotid artery.The tip mark remains in the patient. the reported device and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.

Event Description

New information received.As the tip of the catheter was pressed under the stent, there was no recovery plan for the time being.There was no kink or damage noticed on any of the devices.

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.

Manufacturer Narrative

H3: the echelon-10 catheter was returned for analysis.Upon visual inspection, no damages or irregularities were found with the echelon-10 hub.No bends or kinks were found with the echelon-10 catheter body.However, the catheter body was appeared to be separated/broken at 153.5cm from proximal end.The remaining segment was found to be missing and not returned.It was reported the missing catheter segment remains within the patient.The tubing material of the broken ends exhibited jagged edges and stretching.No other anomalies were observed.The total and usable lengths of the catheter were measured to be within specifications.The echelon-10 micro catheter was flushed, water exited from the distal tip.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed.The broken end of the catheter exhibited with plastic deformation (stretching, and jagged edges) which indicate that the catheter separated when exceeding the tensile strength of the tubing material.However, the root cause for the catheter separation 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: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 16147170
• MDR Text Key: 307184248
• Report Number: 2029214-2023-00054
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: 00847536006256
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B388507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR