MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM FRAMING COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number FC-18-50-3D

Device Problems Break (1069); Stretched (1601)

Patient Problems Ischemia (1942); Foreign Body In Patient (2687); Unspecified Nervous System Problem (4426)

Event Date 09/23/2022

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 an axium prime coil stretched during the procedure and two pipeline vantages failed to open.The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left ica supraclinoid.The max diameter was 19mm, and the neck diameter was 8mm.The patient's blood flow and vessel tortuosity were normal.The landing zone was 2.8mm distal and 3.9mm proximal.It was reported that phenom 17 microcatheter fell back during the pipeline deployment and could not repositioned back inside the aneurysm.The physician tried to retrieve the jailed coil and it stretched and broke/separated/prematurely detached. the coil was not implanted in the intended location, and the stretched coil loop was pushed into the left external carotid artery and a casper 7x30mm stent was deployed to secure it.No additional surgical or medical intervention was required.The pushwire was not bent or broken.The coil had been repositioned twice, no detachment attempts had been made, and the delivery pusher was not rotated.A continuous flush had been administered.Additionally, two pipeline vantages were replaced after they failed to open proximally.The pipelines had not been positioned in a bend and more than 50% had been deployed when they failed to open.The pipelines had been resheathed 2 or less times, and no additional steps were taken to open the devices.They used the introducer and removed the pipelines from the hub. the patient did not experience any injury.Angiographic images post procedure showed some contrast stasis in the aneurysm.The devices were prepared according to the instructions for use (ifu).

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 due to the size of the aneurysm, the physician decided to stent and coil.Catheterisation was difficult.Eventually a hybrid 008 j double-angle wire was used to successfully navigate the phenom 27 into the m1.A traxcess wire was used to navigate a phenom 17 into the aneurysm, where an fc-18-50-3d coil was partially deployed.A ped3-027-400-20 was successfully navigated to the desired distal location in the m1 segment.The stent was flared distal to the below landing zone and pulled back into the location shown.Stent was deployed via the exchange technique.At the neck of the aneurysm, the stent would remain constrained and would not open.As the physician deployed more stent beyond the neck of the aneurysm, the proximal part of the stent appeared to be opening.The neck region remained constrained.Stent was resheashed slightly just past the cavernous bend and forward tension was applied to the entire system to encourage the stent to open around the double bend around the aneurysm neck.The technique was successful after several attempts.The physician then encountered issues with opening the stent around the cavernous bend where the remaining proximal 25%-30% of the device would remain constrained.After repeated attempts to resolve the issue.The decision was taken to retrieve the device.A shorter ped3-027-400-16 was navigated up.Unfortunately, the same sequence of events occurred and the proximal part of the device would not open due to suspected torsion.The device was eventually removed after repeated attempts to remedy the situation.The physician did not wish to release an unopened device around a bend.A third and final attempt was made, a ped3-027-400-12 was navigated up into position and deployed using the same technique described above.The 400-12 device was much shorter and the physician proceeded to release the constrained proximal part of the stent in the straight paraophthalmic segment.With all the attention focused on the pipeline deployment, we did not notice that the phenom 17 had backed out of the aneurysm with the coil still attached (jailed by the pipeline stent) and the phenom 17¿s distal tip markerwas now proximal to that of the deployed pipeline device.The physician attempted to track the microcatheter back into the aneurysm with no success.He then attempted to push the remaining 15cm of the coil into the aneurysm but this did not work either.He then attempted to retrieve the partially deployed coil back into the microcatheter by slowly pulling on the pusher wire.During retrieval of the coil, the physician felt a tug and the coil appeared to have detached, on-screen the coil was no longer being pulled into the microcatheter as the wire was being pulled.The remaining coil loops inside the aneurysm appeared to have formed a knot and were pressing against the stent at the level of the neck.When the delivery wire was removed from the patient, the coil was no longer attached.After screening the chest area, the proximal end of the coil was seen in the descending aorta.After consulting a senior colleague, the decision was made to push the coil loop into the eca rather than leave it in the aorta.By navigating the navien 072 into the eca and using the microcat heter together with guidewires, a significant amount of coil was able to be pushed into the eca.The physician then observed what appeared to be portions of stretched coil being pushed near the carotid bifurcation.A decision was made to protect the ica by deploying a 7mm casper carotid stent.The casper delivery system was able to push all remaining coil out of the navien 072 catheter at the carotid bifurcation.The navien 072 was reposition into the ica and the casper stent was deployed without incident.The procedure was concluded at this point.While pulling on the coil pushwire, the physician felt the tension release unexpectedly, further withdrawal of the pushwire did not result in the coil being retracted from the aneurysm.The coil prematurely/unintentionally released from the delivery wire.

Manufacturer Narrative

B5.Updated with additional information received.Associated with mdr #'s: 2029214-2022-01651, 2029214-2022-01652.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 cause of the ischemic event was not confirmed but considered most likely related to the procedure.It was clarified that after the first pipeline failed to open, the second pipeline was tried and also failed to open so was removed.

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 patient experienced some neurological symptoms as a result of the ischemia, but has since been discharged home.Further details were not provided.Coil premature detachment and stretching was likely due to excessive force caused by the stent pressing on the coil against the vessel wall.

• Brand Name: AXIUM FRAMING COIL
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 15534449
• MDR Text Key: 301122375
• Report Number: 2029214-2022-01650
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162704
• 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,Followup
• Report Date: 12/16/2022

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 Model Number: FC-18-50-3D
• Device Catalogue Number: FC-18-50-3D
• Device Lot Number: 223092659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2022
• Initial Date FDA Received: 10/03/2022
• Supplement Dates Manufacturer Received: 10/27/2022; 12/05/2022; 12/16/2022
• Supplement Dates FDA Received: 11/08/2022; 12/06/2022; 12/16/2022
• Date Device Manufactured: 10/10/2021
• 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 Outcome(s): Other