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

Model Number 145-5091-150

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problems Death (1802); Intracranial Hemorrhage (1891); Low Blood Pressure/ Hypotension (1914); Rupture (2208); Insufficient Information (4580)

Event Date 11/05/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

Medtronic received a report that there was high friction at the distal end of the echelon microcatheter after placing the tip in the right position.Afterwards, it was no possible to bring the microcatheter forward over the wire.While trying to move the microcatheter on the wire, the microcatheter protruded into the aneurysm and ruptured the aneurysm dome.As a rescue, the doctor tried to place coils into the ruptured part, but no coil was possible to pass the catheter tip at the level of the detachment marker.The patient was reported to be deceased as a result of the aneurysm rupture.It was noted all products were prepared per the instructions for use (ifu) during the procedure.The patient was undergoing surgery for aneurysm coiling.It was noted the patient's vessel tortuosity was normal.Ancillary devices include a guider softtip, rebar 18, traxcess, hydrogel coils, bare metal coils, pconus, 2 silk vista.

Event Description

Additional information received indicated the aneurysm was a 10mm dysplastic broad based saccular anterior communicating (acom) artery aneurysm.The traxcess guidewire tip was shaped during the procedure, but no damage was found on the guidewire that was used with a new echelon 10 with no problems.A continuous flush was used throughout the whole procedure.

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.

Event Description

Additional information received reported that the physician was aware of all the devices, including the non-medtronic found within the echelon microcatheter, intentionally used during the procedure and their positions.The damaged microcatheter was primarily inserted for the purpose of coiling after placement of a bifurcation stent through the simultaneously inserted rebar 18 microcatheter.Due to the inappropriateness of a bifurcation stent, the rebar was removed and the approach was changed to double balloon assisted coiling.Therefore a remodelling balloon was placed in a1 with its guidewire being navigated to right a2.Thereafter the echelon microcatheter that already was in place was used to prepare an exchange maneuver in a2 left.Navigation of guidewire to distal left a2 was unremarkably but pushing the echelon over this wire became impossible at the left a1- a2 junction.At this point, all of a sudden, the guidewire could not be moved inside the echelon anymore and during the attempt of guidewire retrieval from a2 the echelon bulged into the aneurysm.

Manufacturer Narrative

Product analysis: the echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed pouch and within an opened echelon-10 inner pouch.The echelon-10 micro catheter total length was measured to be ~157.0cm and the useable length was measured to be ~148.7cm which is within specification.Upon visual inspection, no issues or irregularities were found with the echelon-10 hub.No bends or kinks were found with the echelon-10 catheter body.The echelon-10 micro catheter distal tip was noted pre-shaped.No damages were found with the echelon-10 distal marker / tip.The echelon-10 micro catheter was flushed, water exited from the distal tip.The echelon-10 micro catheter was then tested with an in-house silverspeed-14 guidewire (model: 103-0602-200 lot: 9582100).The in-house silverspeed-14 guidewire was inserted into the echelon-10 micro catheter but was unable to exit the distal tip as it became stuck at ~3.5cm from the distal tip (~0.5cm proximal to the proximal marker).The echelon-10 catheter body was dissected (cut) and what appears to be a non-medtronic flow diverter braid was removed from within the echelon-10 micro catheter.The flow diverter braid appeared to be in good condition.The unconstrained braid length was measured to be ~1.2cm and the width was measured to be ~0.2cm.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ was confirmed.It is likely the flow diverter braid found within the returned echelon-10 micro catheter contributed to the reported resistance of the guidewire and coils used in the event.There was no damage found with the returned echelon-10 micro catheter that would have contributed to the event.B5.Updated with additional information.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.

Manufacturer Narrative

H3.Product analysis updated: the echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed pouch and within an opened echelon-10 (b039692) inner pouch.The guidewire used in the event was not returned.The non-medtronic guidewire has an outer diameter (od) of 0.012¿ (distal) and 0.014¿ (proximal), as per an online source.As per the product labeling, the echelon-10 micro catheter is compatible for use with guidewires with a maximum od of 0.014¿.Therefore, the guidewire was found to be compatible for use with the echelon-10 micro catheter.The echelon-10 micro catheter total length was measured to be ~157.0cm and the useable length was measured to be ~148.7cm which is within specification (specification: 147.0cm ± 1.5cm).Upon visual inspection, no issues or irregularities were found with the echelon-10 hub.No bends or kinks were found with the echelon-10 catheter body.The echelon-10 micro catheter distal tip was noted pre-shaped.No damages were found with the echelon-10 distal marker/tip.The echelon-10 micro catheter was flushed, water exited from the distal tip.The echelon-10 micro catheter was then tested with an in-house silverspeed-14 guidewire.The in-house silverspeed-14 guidewire was inserted into the echelon-10 micro catheter but was unable to exit the distal tip as it became stuck at ~3.5cm from the distal tip (~0.5cm proximal to the proximal marker).The echelon-10 catheter body was dissected (cut) and a non-medtronic diverter braid was removed from within the echelon-10 micro catheter.The braid appears to be in good condition.The unconstrained braid length was measured to be ~1.2cm and the width was measured to be ~0.2cm.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter kick back¿ could not be confirmed.Catheter kick back can occur due to patient vessel tortuosity, high friction, user operational context (i.E.If user advances or retrieves intraluminal device against resistance), vasospasm, or incompatible ancillary devices.In this event, it is likely operational context con tributed to the catheter kick back as resistance was reported with the guidewire.Catheter resistance with guidewire can occur due to incompatible devices, patient vessel tortuosity, catheter damage, guidewire damage, insufficient catheter flushing or lack of continuous flush or flush rate too low, or insufficient guidewire hydration/preparation.It was noted the patient's vessel tortuosity was ¿normal¿, the guidewire was found to be compatible for use with the echelon-10 micro catheter, a continuous flush was maintained, and it was noted all products were prepared as per the instructions for use (ifu) during the procedure.In addition, no damage found with the returned echelon-10 micro catheter that would have contributed to the guidewire resistance.However, the guidewire used in the event was not returned; therefore, any contributing factors (other than device compatibility) could not be assessed and the cause for the guidewire resistance could not be determined.Regarding the customer¿s report of ¿catheter resistance with coils¿ the issue was confirmed.It is likely the non-medtronic flow diverter braid found within the returned echelon-10 micro catheter contributed to the reported resistance with the coils used in the event.It is possible as resistance was encountered delivering the flow diverter the braid prematurely deployed within the echelon-10 micro catheter.Catheter resistance with stent can occur due to incompatible devices, patient vessel tortuosity, catheter damage, stent damage, delivery system damage, insufficient catheter flushing or lack of continuous flush, flush rate too low, or insufficient preparation.It was noted the patient's vessel tortuosity was ¿normal¿, a continuous flush was maintained, and it was noted all products were prepared as per the instructions for use (ifu) during the procedure.The non-medtronic flow diverter is compatible for use with catheter with an id of 0.017¿, as per an online source.The echelon-10 micro catheter has a labeled id of 0.017¿.Therefore, the echelon-10 micro catheter was found to be compatible for use with the non-medtronic flow diverter.In addition, no damage found with the returned echelon-10 micro catheter that would have contributed to the stent resistance.The flow diverter braid appears to be in good condition.However, the flow diverter pusher was not returned; therefore, any contributing factors (i.E.Damage) could not be assessed and the cause for stent resistance 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.

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

2021-11-08 aw_704059105 (for, hcp, rep): the patient was undergoing treatment of a 10.5x7.5x7mm aneurysm at the ramus communicans anterior, with a 1.5mm daughter aneurysm near the base.It was noted that a balloon was used to interrupt blood flow of the ruptured aneurysm.

• Brand Name: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10833057
• MDR Text Key: 216076862
• Report Number: 2029214-2020-01122
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: 00847536006256
• Combination Product (y/n): N
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2022
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B039692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 11/18/2020; 12/05/2020; 04/29/2021; 05/03/2021
• Supplement Dates FDA Received: 12/05/2020; 12/24/2020; 04/29/2021; 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR