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

Model Number 145-5091-150

Device Problems Burst Container or Vessel (1074); Positioning Problem (3009); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2022

Event Type  malfunction  

Event Description

Medtronic received a report that the tip of the echelon 10 microcatheter cracked during the process of filling the coil, a coil experienced resistance, and another coil failed to detach.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the c7 segment of the left internal carotid artery.The max diameter was 6.2mm, and the neck diameter was 5.1mm.The patient's blood flow was normal, and their vessel tortuosity was moderate.The access vessel was the femoral artery, which was 8.1mm in diameter.It was reported that the echelon coil ruptured distally but was intact.There was was no friction/difficulty during delivery, and there was no other damage to the catheter.The injection rate was said to be 100psi.There was resistance when the spring coil entered the distal end of the echelon microcatheter, and it could not be pushed.There was no damage to the coil or catheter.Another coil in the procedure could not be detached.Two attempts each were made with the instant detacher and the manual method.A second instant detacher was not used.There were no issues with the instant detacher. the devices were replaced, and the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).Ancillary devices include a neuronmax sheath and stryker guidewire.

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 reported the aneurysm was located at the c7 segment.It was difficult to place the echelon microcatheter event with the 45° pre-shaped tip; the catheter still required multiple superselections to navigate to the desired location.After 5 coils were delivered, the microcatheter was kicked out of place and could not be positioned properly again.The catheter was found to be damaged when it was withdrawn.It was speculated that the pre-shapable angle of the micro-catheter tip was not ideal, and there were many times of filling coil.During the filling process, the micro-catheter tip was subjected to excessive force, which leaded to cracking.The coils pushed out of the introducer sheaths smoothly.Prior to the non-detachment there were no noted issues with the coils.There was no pushwire damage observed after removal from the patient.It was noted that the coil resistance did not occur in the cracked echelon microcatheter.

Manufacturer Narrative

B5.Updated with additional information received.H6.Device coding updated based on additional information received.Associated with rr #: 2029214-2022-01181.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

Product analysis: as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and without a dispenser coil.(b)(4) axium coils were also returned and will be addressed in pli-20 and pli-30.Visual inspection/damage location details: no damages or irregularities were found with the echelon-10 micro catheter hub and body.The micro catheter tip was found broken at the marker band.The shaping mandrel was found within the distal end of the micro catheter.The shaping mandrel was found to be severely bent at the location of the catheter tip break.Testing/analysis: the echelon-10 micro catheter total length was measured to be ~(b)(4) and the usable length was measured to be ~1 44.6cm, which is within specification (specification: total (ref) = (b)(4), usable = 144.0cm ± 1.5cm).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter puncture¿ was confirmed.The micro catheter was found broken at the marker band.Customer reported the micro catheter tip was subjected to excessive force, which is the likely cause of the catheter tip break.It is also possible that the puncture was caused by distal tip shaped improperly or by the severely bent shaping mandrel found within the returned distal micro catheter.The customer report of ¿catheter kick back¿ and ¿difficulty navigation¿ could not typically be confirmed through device analysis.Possible causes for catheter kickback are patient vessel tortuosity, high friction, user advances/retrieves device against resistance, or vasospasm.Possible causes for ¿difficult navigation¿ are patient vessel tortuosity, damage to the guidewire/coil, damage to catheter or lack of continuous flush during delivery.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: 15048157
• MDR Text Key: 304082821
• Report Number: 2029214-2022-01180
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2023
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B207137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• 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 Age: 52 YR
• Patient Sex: Male