MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA FLOW PLUS 6F; CATHETER, THROMBUS RETRIEVER

Model Number DA6131ST-ASP-US-OD

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

Patient Problems Vasoconstriction (2126); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 06/22/2023

Event Type  Injury  

Manufacturer Narrative

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: based on a review of the last 2 years of complaint data, and 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 potential complications include but are not limited to: vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudo aneurysm, seizure, stroke, infection, vessel dissection, thrombus formation, and death.Precautions exercise care in handling the sofia flow plus aspiration catheter to reduce the chance of accidental damage.Use caution when manipulating the sofia flow plus aspiration catheter in tortuous vasculature to avoid damage.Avoid advancing or withdrawal against resistance until the cause of resistance is determined.The presence of calcification, irregularities, or other devices may damage the sofia flow plus aspiration catheter and potentially affect its insertion or removal.Maintain perfusion of heparinized saline for inner lumen of the sofia flow plus aspiration catheter to prevent thrombus formation.Do not use automated high-pressure contrast injection equipment with the sofia flow plus aspiration catheter because it may damage the catheter.The catheter has hydrophilic coating over the distal 60 cm.Make sure to hydrate the coating before use with heparinized saline.Once the catheter is hydrated, do not allow it to dry.Delivery of the sofia flow plus aspiration catheter 6.Navigation through the vasculature b.Insert the guidewire and / or microcatheter into the sofia flow plus aspiration catheter and advance the guidewire / microcatheter until the guidewire / microcatheter and the sofia flow plus aspiration catheter are aligned at the distal end.C.Using the introducer sheath provided in the package, carefully insert the sofia flow plus aspiration catheter and the guidewire through a hemostatic valve of the femoral sheath.Warning: do not over-tighten the hemostatic valve on the sheath or guide catheter through which the sofia flow plus aspiration catheter is inserted.Over-tightening may result in damage to the sofia flow plus aspiration catheter.E.Under fluoroscopic guidance, advance or withdraw the sofia flow plus aspiration catheter over the guidewire and / or microcatheter until the desired position is attained.Select vessels by slowly torqueing the sofia flow plus aspiration catheter if necessary.Warning: do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Warning: torqueing the sofia flow plus aspiration catheter excessively while kinked may damage the device resulting in separation of the device.Withdraw the entire device (the device, microcatheter, and guidewire) if the device is severely kinked.Aspiration through the sofia flow plus aspiration catheter 8.Under fluoroscopic guidance, position the distal tip of the sofia flow plus aspiration catheter at the desired vessel location.Warning: do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Warning: torqueing the sofia flow plus aspiration catheter excessively while kinked may damage the catheter resulting in separation of the catheter.Withdraw the catheter system, including the sofia flow plus aspiration catheter, microcatheter, and guidewire if the sofia flow plus aspiration catheter is severely kinked.9.Attach aspiration tubing to the aspiration pump and turn on the pump (refer to the directions for use of the aspiration tubing and aspiration pump manual).Confirm that the aspiration gauge reads -20 inhg.Ensure the stopcock on the aspiration tubing is in the closed position.13.To begin aspiration, turn the aspiration tubing stopcock to the open position and check to see if blood, thrombus, or embolus are aspirated through the system.14.If after 10 seconds blood is still observed flowing through the system, stop aspiration.To stop aspiration, turn aspiration tubing stopcock to the closed position.Carefully reposition the distal tip of the sofia flow plus aspiration catheter to engage the thrombus and resume aspiration.15.If flow is restricted or absent, maintain aspiration to make sure any thrombus or embolus is fully engaged with the distal tip of the sofia flow plus aspiration catheter.With the thrombus or embolus fully engaged, slowly pull back the sofia flow plus aspiration catheter and completely withdraw out of the patient.Warning: excessive aspiration with the distal tip of the sofia flow plus aspiration catheter engaged with vessel wall may cause vessel injury.16.With the sofia flow plus aspiration catheter outside of the patient body, flush the catheter to clear the catheter of any thromboembolic material that may be inside.Warning: do not attempt to clear inner lumen of the sofia flow plus aspiration catheter by infusion while keeping the device in the patient body.Remove the sofia flow plus aspiration catheter from the patient body before attempting to clear the lumen.17.If repeated access to the vasculature with the same device is desired, flush and clean the inner lumen of the device by infusion.Inspect the device for any damage.Reintroduce the sofia flow plus aspiration catheter into the body and follow steps 6 & 7 in the ¿delivery of the sofia flow plus aspiration catheter¿ section to navigate the catheter to the target site.Warning: do not use the device if any damage or irregularities are observed.Investigation conclusion: 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

As reported in the sofast/restore, that on the day of index thrombectomy procedure, the patient experienced multiple adverse events.Vasospasm observed involving accessed vascular tree was noted.Issue resolved the same day without sequelae.There was distal emboli/clot migration in m1 that required intervention with repeat thrombectomy, which resolved the next day without sequelae, and assessed as possibly related to study device, study disease, and definitely to thrombectomy procedure.Reportedly, distal emboli/clot migration resolved."ir stroke angiogram", "right internal carotid cerebral angiogram #2 (during thrombectomy).This angiogram was performed in ap and lateral projection.This angiogram was performed immediately after first pass via sofia 6 french reperfusion catheter.Severe vasospasm of the right m1 segment of the right middle cerebral artery; however, good distal perfusion was seen.Small clot was seen in the angular branch of the inferior division of the right middle cerebral artery.This would classify as tic i 2c reperfusion.The patient also experienced embolization to a new territory that was resolved without sequelae with medication, assessed as possibly related to study device and definitely to thrombectomy procedure.Reportedly, embolization to a new territory resolved.Ir stroke angiogram - after thrombectomy, a balloon guide was pulled back in the common carotid artery and a cervical carotid angiogram was performed demonstrating severe stenosis of the internal carotid artery with slow flow distally.Hence an embolic protection device was advanced and filter was deployed in the distal cervical internal carotid artery.Using the rapid exchange method, a 8-6 x 40mm stent was advanced and deployed across the stenosis.Balloon angioplasty was not needed as no residual stenosis was seen after stent deployment.The filter was retrieved utilizing retrieval system.A bolus of iv cangrelor was given simultaneously followed by infusion.A follow-up right common carotid angiogram demonstrated intermediate stent thrombosis.Attempt was made to re-access the stent with a microcatheter and sofia reperfusion catheter was successful.A cerebral angiogram was performed via the sofia reperfusion catheter demonstrating re-occlusion of the right middle cerebral artery from a partially occlusive thrombus.There is also a distal thrombus seen in the right pericallosal artery.The intermediate catheter was re-advanced into the region of right middle cerebral artery occlusion.Aspiration was performed via the sofia 6 french reperfusion catheter for 3 minutes.After aspiration, the sofia 6 french intermediate catheter was slowly pulled back.A follow-up angiogram via the balloon guide catheter demonstrated complete recanalization of the right middle cerebral artery with moderate vasospasm in good distal reperfusion.Patient continued to have the right pericallosal artery occlusion at the a3 segment.At this time, it was decided to address the right cervical carotid.A follow-up cervical carotid angiogram demonstrated stent patency with distal right internal carotid artery dissection immediately distal to the stent.As it appears to be flow-limiting, it was decided to place another carotid stent.The patient also experienced carotid artery dissection assessed as possibly related to study device and to thrombectomy procedure, and required intervention with repeat thrombectomy and carotid stenting.Issue resolved without sequelae on (b)(6) 2023.A carotid stent was placed after thrombectomy, which was thrombosed due to ica dissection leading to repeat thrombectomy and second carotid stent placement.Outcome unchanged.

• Brand Name: SOFIA FLOW PLUS 6F
• Type of Device: CATHETER, THROMBUS RETRIEVER
• 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: 18379064
• MDR Text Key: 331179870
• Report Number: 2032493-2023-01139
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00842429108482
• UDI-Public: (01)00842429108482(11)230327(17)260228(10)0000341553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: DA6131ST-ASP-US-OD
• Device Lot Number: 0000341553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2023
• 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; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female