MAUDE Adverse Event Report: MICROVENTION, INC FRED; INTRALUMINAL DEVICES

Model Number FRED4518-A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Aneurysm (1708)

Event Date 10/26/2022

Event Type  Injury  

Manufacturer Narrative

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.The device was implanted in the patient and not returned to the manufacturer for evaluation.Images were not available for review by the manufacturer; however, the investigation is currently ongoing as medical notes were provided and are being reviewed.Upon completion of the investigation, a supplemental mdr will be submitted.

Event Description

It was reported through the clinical study sealant study " the treatment of the dissecting aneurysm that ruptured once on (b)(6) 2020, and rebled on (b)(6) 2020, both treated by embolization coiling.Then, the aneurysm was treated on (b)(6) 2020, using a flow diverter (fred).On (b)(6) 2020, a control angiogram showed a voluminous area of recanalization despite the stent, the packing of coils is again pushed to the bottom of the sac.On (b)(6) 2020, endovascular treatment was completed with placement of a coil in the aneurysmal dissection and another flow diverter stent in overlap.At short-term follow up visit on (b)(6) 2021, the neurological evaluation of the patient was mrs score 2.According to the data collected in the ecrf (control imaging), there was still a residual aneurysm, but the occlusion was better with a decrease in sac size.At long-term follow up visit on (b)(6) 2021, the neurological evaluation of the patient was mrs score 2.Control imaging data is not captured in ecrf.

Event Description

See section h10.

Manufacturer Narrative

Procedure note review: procedure note medical review for (b)(4).A detailed review of the of the procedure note data has been performed for (b)(4).Data review indicates that the patient presented with a fisher iv subarachnoid hemorrhage, without obvious aneurysm visualized on ct.Ct imaging identified a subarachnoid hemorrhage quite diffuse, predominantly in the left sylvian valley.Report data indicates that images (not provided) show a saccular aneurysm of the distal portion of the left carotid siphon, oriented medialernally.This aneurysm has an extremely wide neck, 2.5 mm wide and a depth of about 3.5.A 4 mm balloon supported by a traxcess 14 guidewire, in order to position it opposite the aneurysmal neck.Control seriography showing no radio-anatomical complication.Data indicates that the endovascular treatment of a ruptured wide-necked saccular aneurysm of the distal portion of the left carotid siphon catheterization and difficult aneurysm occlusion using a remodeling technique was performed with subtotal-partial occlusion, without radio-anatomical complications from procedure performance date 8-6-2020.Data indicates, (no date provided) on the procedure note that the patient experienced onset of right hemiplegia with aphasia followed by a seizure.Performance of an emergency mri (no images provided) showed a hemorrhagic recurrence with a large left frontal parenchymal hematoma.Icp was performed, and decision was made to perform a diagnostic and +/- therapeutic angiography.Data indicates that images (no images provided) show an aneurysmal regrowth: a false sac of about 4 mm of great axis developed from the aneurysmal neck, probably responsible for this hemorrhage, which pushes down the packing of coils previously put in place.Report data further indicates that there is a new false bag which is laterally-superiorly oriented and around the shell packing, there seems to be also a small millimetric regrowth, on the inferior side.Occlusion of the false sac appeared by co "11 using a remodeling technique with the existence of a marked vasospasm on the m1 and a 1 segment.Data review further indicates that false dissecting aneurysm of the supra-clinoid portion of the left carotid siphon, having bled twice, and treated endovascularly by simple coiling on 08.06.2020 and on 15.06.2020.New recurrence in the form of a large false sac was observed on the last follow-up mri.The decision was made to trailer this area of dissection outside the period of vasospasm by placing a flow diverter stent.Data indicates that images (no images provided) confirmed the new pseudo-aneurysmal recanalization, in the form of a large sac measuring 11 mm in long axis by 8 mm, with a wide neck, involving the supra-clinotdian portion of the carotid siphon.Data further indicates that there is a residual but significant spasm on the proximal third of the left m1 segment from the beginning of the procedure.The report data indicates that the ascent of the microcatheter in the left middle cerebral artery immediately causes a worsening of this vasospasm, with a defect of opacification of m1 and the physician decided to administer intra-arterial papaverine and to wait about ten minutes.The control images (no images are provided for review during this procedure review) show a partial lifting of this vasospasm, allowing nevertheless the navigation.Report data indicates that a 4.5mmx25mm flow diverter fred stent was mounted.It was decided to deploy the fred stent several times, the first attempts were unsuccessful due to systematic downward sliding of the stent.Physician reports that after the fourth attempt, the stent was satisfactorily opened just opposite the carotid siphon termination and stabilized.The patient was then monitored in the surgical continuum of care.Clinically, the patient remained somnolent, and there was still right hemiparesis predominantly in the upper limb and mixed aphasia.The cerebral mri of controls performed on 16.07.2020 showed a complete occlusion of the false aneurysm sac without new recanalization.There were no ischemic complications following stenting.Procedure note medical review conclusion for (b)(4).A detailed medical review of the procedure note data for (b)(4) has been completed.Report data indicates that a 4.5mmx25mm flow diverter fred stent was mounted.It was decided to deploy the fred stent several times, the first attempts were unsuccessful due to systematic downward sliding of the stent.Physician reports that after the fourth attempt, the stent was satisfactorily opened just opposite the carotid siphon termination and stabilized.The patient was then monitored in the surgical continuum of care.Clinically, the patient remained somnolent, and there was still right hemiparesis predominantly in the upper limb and mixed aphasia.The cerebral mri of controls performed on 16.07.2020 showed a complete occlusion of the false aneurysm sac without new recanalization.There were no ischemic complications following stenting.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 is 1 other complaint from the last 2 years recorded in the complaint handling system with this batch number at the time of this investigation: p22-0835.At the time of this investigation, no systemic issues have been identified for this batch number that would have caused or contributed to the reported event.Ifu review (additional information can be found in the ifu): potential complications possible complications include but are not limited to the following: bleeding or hemorrhage including intracerebral, retroperitoneal or other locations.Complications of arterial puncture including pain, local bleeding (hematoma) or injury to the artery or adjacent nerves.Device migration.Distal embolization.Headache.Incomplete aneurysm occlusion.Neurologic deficits including stroke and/or death.Perforation or dissection of the vessel(s).Pseudoaneurysm formation.Rupture or perforation of aneurysm.Transient ischemic attack (tia) or ischemic stroke.Vasospasm.Vessel occlusion.Vessel stenosis or thrombosis.Preparation for use: device and delivery system selection.Appropriate selection of the fred system is important for patient safety.In order to choose the optimal fred system model size for any given lesion, examine pre-treatment angiograms for correct and accurate vessel measurements.Directions for use gain vascular access according to standard angiographic practice and perform diagnostic angiogram to document target aneurysm and parent vessel to confirm vessel diameter.Place appropriate size guide catheter according to standard practice.Per physician discretion, if embolization coils are going to be used along with the fred system, position a.017 inch (0.43 mm) inner diameter (or suitable size) microcatheter (to be utilized for coil embolization) coaxially into the target aneurysm.If the fred system is going to be used without embolization coils, disregard this step.Coaxially navigate a microcatheter (microvention headway 27 microcatheter) over a guidewire at least 15 mm distal to the aneurysm neck or target location.Remove the guidewire.Maintain flush through the microcatheter(s) per standard endovascular practice.Select an appropriate-sized fred system (refer to figure 3 and fred system inservice guide) according to the size of the parent vessel/aneurysm neck.Note: the fred system implant foreshortens significantly (up to 60%) as it expands to the diameter of the parent vessel.Take implant foreshortening into account when sizing and deploying the fred system.Carefully inspect the package for damage to the sterile barrier.Peel open the pouch using aseptic technique and place the dispenser coil into the sterile field.8.A.Unclip the molded cap attached to the delivery wire from the dispenser coil.Pull on the proximal end of the delivery wire until the introducer exits the dispenser coil.Hold the delivery wire and introducer together while continuing to remove the entire device.B.After removal from the dispenser coil, carefully push on the delivery wire and in a bowl of saline, only partially deploy the fred implant up to 5 mm or 50% (whatever occurs first, being careful not to detach the implant) from the distal introducer tip.Check for the following: implant distal marker uniformity.Implant distal end shows even displacement with no entanglement.Implant tracks smoothly through introducer.Warning: do not fully deploy fred system.With the fred implant and introducer sheath positioned and hydrated within the bowl of saline, gently manipulate the fred implant within the saline to hydrate the implant and minimize visible air bubbles.Carefully pull back on the delivery wire to fully retrieve the fred implant and delivery wire tip within the introducer.Warning: do not continue if any defect is observed; return the unit to microvention, inc.Confirm that the device is entirely within the introducer, the tip of the delivery wire is not kinked and the introducer tip is not damaged.Do not continue if either defect is observed; return the unit to microvention, inc.10.Partially insert the distal end of the introducer into the rhv connected to the headway 27 microcatheter.Tighten the rhv locking ring.Flush the rhv with sterile saline and verify that fluid exits the proximal end of the introducer, hydrating the introducer.Warning: purge the fred system carefully to avoid the accidental introduction of air into the system.Untighten the rhv locking ring and advance the introducer until it is fully engaged with the headway 27 microcatheter hub, then tighten the rhv locking ring.Warning: confirm that there are no air bubbles trapped anywhere in the system.Caution: the introducer must be properly engaged with the microcatheter hub to enable fred system to be introduced into the microcatheter.Advance the delivery wire to transfer the fred system from within the introducer into the microcatheter.Warning: do not torque the delivery wire while advancing or retracting the fred system.Continue advancing the delivery wire into the microcatheter until the proximal tip of the delivery wire enters the introducer.Loosen the rhv locking ring, remove the introducer, and set it aside.Note: fluoroscopy may be used up to this point at the physician's discretion.Warning: do not apply undue force.If resistance is encountered at any point during delivery or manipulation, withdraw the unit and select a new fred system.Track the device through the microcatheter to the tip.Carefully advance until the device exit marker on the proximal end of the delivery wire approaches the rhv.At this time, fluoroscopic guidance must be initiated.15.Position the fred system for deployment by aligning the fred system implant distal radiopaque end markers approximately 7 mm past the aneurysm neck.Note: a slow, proper push/pull technique, encompassing sufficient delivery wire push force, in addition to an opposing microcatheter withdrawal force, to remove excess microcatheter slack while maintaining the microcatheter tip within the center of the parent vessel, will facilitate properly deploying the fred system at the proper location, to achieve full expansion and good vessel apposition.Note: if applicable, verify microcatheter placed into aneurysm in step 3 is still properly positioned for coil delivery.Caution: using a rapid microcatheter withdrawal technique to deploy the fred system is not recommended and may result in device elongation or improper deployment.Be aware of delivery wire tip position during deployment.If fred system positioning is not satisfactory, the implant may be recaptured and repositioned if it is not fully deployed.The implant may be recaptured until the point where the distal-most wire marker, collocated distal to the implant proximal markers, is aligned approximately 50% of length proximal to the microcatheter distal marker band.Caution: if resistance is felt while recapturing the device, do not continue to recapture.Withdraw the microcatheter slightly to unsheath the device (without exceeding the recapture limit), and then attempt to recapture again.Caution: the fred system must not be re-deployed more than three times.Caution: the fred system delivery wire should not be utilized as a guidewire.Do not torque the fred system.A torque device should not be used.If fred system positioning is satisfactory, carefully advance the delivery wire while retracting the microcatheter as needed to minimize slack, maintaining the microcatheter around the center of the parent vessel, to allow the implant to deploy across the neck of the aneurysm.Ensure the implant proximal radiopaque end markers are approximately 7 mm proximal to the aneurysm neck for adequate coverage.Note: the fred system will expand and may foreshorten up to 60% from its undeployed length.Visually verify opening of the proximal end, ensuring that the microcatheter distal tip marker is pulled back, adequately away from the implant proximal end, to allow the proximal end to freely open.Push forward on the delivery wire to assist in maintaining access within the implant as needed.Note: visualize and refer to implant radiopaque end markers to maintain adequate implant length of approximately 7 mm on each side of the aneurysm neck/target location to ensure appropriate coverage.Warning: do not detach the fred system if it is not properly positioned in the parent vessel.Warning: if applicable, observe fred system marker position during coiling procedure to ensure that the device does not migrate.Prior to removing the delivery wire and if necessary, position the microcatheter distal to the implanted device to maintain access through the implanted device.Remove and discard the delivery wire.Caution: the fred system delivery wire should not be utilized as a guidewire.Do not torque the fred system.A torque device should not be used.Carefully inspect the deployed fred implant under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the implant is not fully apposed or is kinked, consider utilizing a suitable microguidewire and/or occlusion balloon catheter to fully open the implant.If applicable, detachable coils may be delivered into the aneurysm sac following conventional methods, utilizing the jailed microcatheter from step 3.Verify that the implant remains patent and properly positioned.Note: the jailed microcatheter should be carefully removed to avoid dislodging the fred implant.After completing the procedure, withdraw and discard all applicable accessory devices.Caution: carefully watch the fred implant distal and proximal markers when passing through the implanted device with other devices to avoid displacing the implant.

Event Description

N/a.

Manufacturer Narrative

Only images were provided for this investigation as the product was not returned for evaluation.There are 2 dsa runs of the left ica, dated (b)(6), 2020; ap and lateral.They demonstrate a large recurrent (post-coiling) left pcom aneurysm.There are no measurements and the neck is not shown on a working projection.A fred has been positioned from the supraclinoid ica back to the posterior segment of the horizontal cavernous ica.The device appears well-apposed and there is mild stasis in the recurrent aneurysm.There as well flat-panel cta images that demonstrate the same.The cause of the described problem is not explained by these images.Without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused on contributed to the reported event.

• Brand Name: FRED
• Type of Device: INTRALUMINAL DEVICES
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15974337
• MDR Text Key: 305415562
• Report Number: 2032493-2022-00551
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00816777025562
• UDI-Public: (01)00816777025562(11)190722(17)220630(10)190722542
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: FRED4518-A
• Device Lot Number: 190722542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female