MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ONYX AVM; AGENT, INJECTABLE, EMBOLIC

Model Number 105-7100-060

Device Problems Entrapment of Device (1212); Premature Activation (1484)

Patient Problems Vasoconstriction (2126); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2022

Event Type  Injury  

Event Description

Medtronic received information that a rist catheter separated in the distal section due to entrapment in onyx.The physician went radial for the intervention with 6f rist 106f-071-95 and it ended up kinking at the arch.Onyx 18 was used to embolize the middle meningeal artery and headway duo was used as his microcatheter.When trying to remove the headway duo the physician noticed it was stuck in the onyx cast and at this point he didn't realize that rist had kinked.The physician pulled the headway duo slightly and locked the touey in hopes that the headway duo would release from the onyx cast.He did this several times and while doing this the headway duo fractured around the mid body of the catheter.The physician pulled out the proximal half of the headway duo and then removed rist which is when the physician noticed rist was kinked.With the distal half of headway duo was still in the patient the physician had to use a microsnare to remove it first from the onyx cast and then from the patient.The patient was discharged the next day.Distal portion of headway duo stuck in onyx cast and middle portion possibly entrapped in the kink of rist per physician.The catheter was entrapped in the guide catheter.The catheter was kinked in the middle.The broken segments were removed from patient.No surgical or medical intervention was required.The physician paused during injection.The devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as per ifu.The patient was undergoing middle meningeal artery (mma) embolization.The access vessel was the radial artery.The vessel tortuosity was minimal.No patient symptoms or complications were reported.Ancillary devices: 6f slender sheath, headway duo microcatheter, syncro 010 guidewire.

Manufacturer Narrative

Event related to regulatory report number: 2029214-2022-01552.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

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 the hcp who reported that the complication did not arise from the embolisate, it arose from the then in the aortic arch of the guide catheter.

Event Description

Additional information received reported the dead space of the delivery catheter was filled with dmso.There was no onyx reflux.The injections rate was followed as indicated in the competitor's ifu.Liquid embolic agent did not get embedded in an unintended location.There was no vasospasm.

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 information that a rist catheter 106f-071-95 kinked and ruptured intact in the middle.A micropuncture was used using ultrasound for access in the right radial artery.A 6 french sheath was placed in the right radial artery.At this point a rist guide catheter over a simmons select over an 035 glidewire was then brought up into the aortic arch and used to selectively catheterize left common carotid artery.Under roadmap guidance the guide catheters brought up into the distal external carotid artery and internal maxillary artery.Ap and lateral runs were performed demonstrating location the middle meningeal artery.Under negative roadmap guidance initially a mini scepter with a balt hybrid wire was attempted but this was unsuccessful.At this point a headway duo 156 over a synchro 2 microwire was then used to access the middle meningeal artery.This microcatheter was brought all into the distal portion of middle meningeal artery.Under negative roadmap imaging we were able to inject onyx 18 and embolized the vessel success fully.During removal of the microcatheter, catheter fractured and the fracture portion of the catheter was removed from the guide.A significant portion of the microcatheter was left in place from the middle meningeal artery all the way down into the common carotid artery.Because of this a 7 mm snare was attempted to try to retrieve part of the catheter.During this attempted part of the catheter was also fractured off but it was noted that the guide catheter from the radial approach had kinked and was the cause of the likely fracture of the microcatheter.At this point multiple attempts were used to try to straighten of the guide catheter and an 8 french sheath was placed in right common femoral artery.Tracstar guide catheter over a simmons select guide catheter over an 035 glidewire was then brought up into the aortic arch and used to select and catheterize left common carotid artery.Under negative roadmap guidance the guide catheter was also brought up into the external carotid artery and multiple attempts using a combination of snares was done to try to grasp the microcatheter.This was unsuccessful.At this point our attention was then turned back to the radial guide catheter and an 035 was used to reduce the kink and fracture catheter and a 2 mm there was then brought up to the radial ri st guiding used to select the fraction into the microcatheter successfully.Under right visualization this was then removed and the entire fragment of the microcatheter was removed from the head.Both guide catheters removed.Injections were done in both the internal and extra carotid artery to confirm that there was no middle meningeal artery and there was no other signs of stroke.The guide and sheath were withdrawn and puncture site hemostasis obtained with radial artery band.The femoral access site was closed with an 8 french angio-seal.The patient was undergoing embolization of the middle meningeal artery for treatment of subdural hematoma.Radial access vessel.Patient symptoms or complications were unknown.  ancillary devices: glidesheath slender radial access 6f stainless steel (80-1060) sheath, headway duo microcatheter, glidewire peripheral guidewire, hydrophilic coated, standard, 3mm flexible angled tip (gr3508) guidewire, onyx 18 les (b355318) liquid embolic additional information received reported that the microcatheter fracture occurred after successful embolization, and a significant portion of the catheter was left inside the vessel.This was likely related to a kink in the rist guide catheter.After multiple retrieval attempts, the other catheter fragment was removed with no evidence of patient defects.Corelab imaging from the procedure showed severe onyx cast in the veins.Additional information received reported lesion characteristics: left side chronic sdh, parietal, 22 mm thickness, homogenous.Vessel tortuosity was normal.No acute events.Patient is recovering very well.Procedural angiogram, 24 hour ct was conducted.During removal of the microcatheter, catheter fractured and the fracture portion of the catheter was removed from the guide.A significant portion of the microcatheter was left in place from the middle meningeal artery all the way down into the common carotid artery.Because of this a 7 mm snare was attempted to try to retrieve part of the catheter.During this attempted part of the catheter was also fractured off but it was noted that the guide catheter from the radial approach had kinked and was the cause of the likely fracture of the microcatheter.At this point multiple attempts were used to try to straighten of the guide catheter and an 8 french sheath was placed in right common femoral artery.Tracstar guide catheter over a simmons select guide catheter over an 035 glidewire was then brought up into the aortic arch and used to select and catheterize left common carotid artery.Under negative roadmap guidance the guide catheter was also brought up into the external carotid artery and multiple attempts using a combination of snares was done to try to grasp the microcatheter.This was unsuccessful.At this point our attention was then turned back to the radial guide catheter and an 035 was used to reduce the kink and fracture catheter and a 2 mm there was then brought up to the radial rist guiding used to select the fraction into the microcatheter successfully.Under right visualization this was then removed and the entire fragment of the microcatheter was removed from the head.Both guide catheters removed.Injections were done in both the internal and extra carotid artery to confirm that there was no middle meningeal artery and there was no other signs of stroke.

Manufacturer Narrative

Additional information was previously submitted in manufacturer report # 2029214-2022-01554.Upon further review, these are duplicate events.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: ONYX AVM
• Type of Device: AGENT, INJECTABLE, EMBOLIC
• 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: 15414464
• MDR Text Key: 306278688
• Report Number: 2029214-2022-01553
• Device Sequence Number: 1
• Product Code: MFE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/07/2023

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: 105-7100-060
• Device Catalogue Number: 105-7100-060
• Device Lot Number: B355318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 10/04/2022; 10/31/2022; 03/07/2023
• Supplement Dates FDA Received: 10/26/2022; 11/11/2022; 03/07/2023
• 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: 78 YR
• Patient Sex: Female