MAUDE Adverse Event Report: MICROVENTION, INC WEB SL 27 SINGLE LAYER; INTRASACCULAR DEVICES

Model Number W2-8-4-MVI-3

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  Injury  

Manufacturer Narrative

The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The web device rotation could not be confirmed.A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.If additional information is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.H3 other text : device remains implanted.

Event Description

As reported through the clinical study web pas.The patient had the web device implanted, and a few minutes after the implant the physician did an imaging run.They noticed that the device had rotated in the aneurysm approximately 40 degrees.The device did not leave the aneurysm/targeted implant location.It didnt cause parent vessel stenosis, didnt cause any patient injury/ae, and there were no additional/adjunctive therapies required to treat the aneurysm.The device remains implanted.

Manufacturer Narrative

A visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu): potential complications potential complications include but are not limited to the following: vessel puncture site hematoma, aneurysm perforation or rupture, hemorrhage, edema, thromboemboli, transient ischemic attack, ischemic stroke, neurologic deficits, parent artery occlusion, ischemia, vessel dissection or perforation, vascular thrombosis, vasospasm, device migration or misplacement, premature detachment, headache, post-embolization syndrome, infection and death.The web embolization device requires the use of fluoroscopy.Potential complications related to angiographic and fluoroscopic radiation doses include, but are not limited to, alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia.The probability of occurrence of complications may increase as procedure time and number of procedures increase.Other procedural complications including but not limited to anesthetic and contrast media risks, hypotension, hypertension and access site complications.Warnings ¿ do not allow an inappropriately sized or non-optimally positioned web embolization device to reside in the aneurysm significantly beyond the activated clotting time (act).Experience has shown that thrombus formation can also prevent the web embolization device from full deployment and recapture.To minimize the risks of potential complications, the status of the patient¿s anti-platelet medication regimen should be considered when deciding to remove the entire web embolization device from the aneurysm prior to deployment/detachment for replacement by a new web embolization device.Procedure - instructions for use web embolization device size selection 12.The correct web size is approximately 1 mm larger than the average aneurysm diameter and approximately 1 mm smaller than the smallest aneurysm height introduction and deployment of the web embolization device 28.Under fluoroscopic guidance, slowly advance the web embolization device out the tip of the microcatheter.Continue to advance the web embolization device into the lesion until optimal deployment is achieved.The following may require repositioning or removal of the web embolization device and/or repositioning of the microcatheter.A.If the web embolization device size is not appropriate, remove and replace with another web embolization device.B.If undesirable movement of the web embolization device is noted following placement and prior to detachment, remove the web embolization device.Movement of the web embolization device may indicate that the web embolization device could migrate once it is detached.C.If the web embolization device (implant) does not fully open: i.Retrieve the implant, reposition the microcatheter further proximally and re-deploy the implant to allow more room for expansion, or ii.Replace the implant with another implant of the same or alternate size.The web embolization device should not be retracted and deployed more than twice.After two attempts, remove the web embolization device and replace with another web embolization device of the same or alternate size.To minimize the potential risk of thrombus, do not allow an inappropriately sized or non-optimally positioned web embolization device to reside in the aneurysm significantly beyond the activated clotting time (act).Experience has shown that thrombus can also prevent the web from full deployment and recapture.To minimize the risks of potential complications, the status of the patient¿s anti-platelet medication regimen should be considered when making a decision to remove the entire system from the aneurysm for replacement by a new web embolization device.The physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

Event Description

No additional information was provided.Please see h6 and h10.

Event Description

As reported through the clinical study web pas: the patient had the web device implanted, and a few minutes after the implant the physician did an imaging run.They noticed that the device had rotated in the aneurysm approximately 40 degrees.The device did not leave the aneurysm/targeted implant location, did not cause parent vessel stenosis, did not cause any patient injury/ae, and there were no additional/adjunctive therapies required to treat the aneurysm.The device remains implanted.It was confirmed no imaging of the reported incident is available.Updated information received provided the following: event term: recurrence of basilar tip aneurysm event start date: 20-feb-2024 was this a serious ae? : no intervention : x relationship to study device : possible relationship to index endovascular procedure : not related relationship to use of ancillary device : not related relationship to study disease : probable relationship to concomitant disease : not related ae outcome : ongoing based on the information provided, the reported recurrence of basilar tip aneurysm is indicated to be related to the study disease and possibly the study device, web.The intervention noted is referring to needing retreatment, however, this has not been performed or scheduled yet as patient needed to delay.

Manufacturer Narrative

Items returned: - n/a.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu): potential complications potential complications include but are not limited to the following: vessel puncture site hematoma, aneurysm perforation or rupture, hemorrhage, edema, thromboemboli, transient ischemic attack, ischemic stroke, neurologic deficits, parent artery occlusion, ischemia, vessel dissection or perforation, vascular thrombosis, vasospasm, device migration or misplacement, premature detachment, headache, post-embolization syndrome, infection and death.The web embolization device requires the use of fluoroscopy.Potential complications related to angiographic and fluoroscopic radiation doses include, but are not limited to, alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia.The probability of occurrence of complications may increase as procedure time and number of procedures increase.Other procedural complications including but not limited to anesthetic and contrast media risks, hypotension, hypertension and access site complications.Warnings ¿ do not allow an inappropriately sized or non-optimally positioned web embolization device to reside in the aneurysm significantly beyond the activated clotting time (act).Experience has shown that thrombus formation can also prevent the web embolization device from full deployment and recapture.To minimize the risks of potential complications, the status of the patient¿s anti-platelet medication regimen should be considered when deciding to remove the entire web embolization device from the aneurysm prior to deployment/detachment for replacement by a new web embolization device.Procedure - instructions for use web embolization device size selection 12.The correct web size is approximately 1 mm larger than the average aneurysm diameter and approximately 1 mm smaller than the smallest aneurysm height introduction and deployment of the web embolization device 28.Under fluoroscopic guidance, slowly advance the web embolization device out the tip of the microcatheter.Continue to advance the web embolization device into the lesion until optimal deployment is achieved.The following may require repositioning or removal of the web embolization device and/or repositioning of the microcatheter.A.If the web embolization device size is not appropriate, remove and replace with another web embolization device.B.If undesirable movement of the web embolization device is noted following placement and prior to detachment, remove the web embolization device.Movement of the web embolization device may indicate that the web embolization device could migrate once it is detached.C.If the web embolization device (implant) does not fully open: i.Retrieve the implant, reposition the microcatheter further proximally and re-deploy the implant to allow more room for expansion, or ii.Replace the implant with another implant of the same or alternate size.The web embolization device should not be retracted and deployed more than twice.After two attempts, remove the web embolization device and replace with another web embolization device of the same or alternate size.To minimize the potential risk of thrombus, do not allow an inappropriately sized or non-optimally positioned web embolization device to reside in the aneurysm significantly beyond the activated clotting time (act).Experience has shown that thrombus can also prevent the web from full deployment and recapture.To minimize the risks of potential complications, the status of the patient¿s anti-platelet medication regimen should be considered when making a decision to remove the entire system from the aneurysm for replacement by a new web embolization device.The physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

Manufacturer Narrative

B5: additional information received.H6: codes updated based on additional information.H10: the additional information received does not impact the previously submitted investigation or other data submitted except as noted.The investigation remains unchanged.

Event Description

Updated information received notes this ae was adjudicated by the cec on 28mar2024 as definitely related to the device and not related to procedure.Intervention clarification was received.Retreatment for the recurrence of basilar tip aneurysm was performed on (b)(6) 2024 with 2x coils (target tetra) and 1x neuroform stent.

• Brand Name: WEB SL 27 SINGLE LAYER
• Type of Device: INTRASACCULAR DEVICES
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16753308
• MDR Text Key: 313620514
• Report Number: 2032493-2023-00666
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429107157
• UDI-Public: (01)00842429107157(11)220322(17)270228(10)0000169613
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W2-8-4-MVI-3
• Device Catalogue Number: W2-8-4
• Device Lot Number: 0000169613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2022
• 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; Required Intervention