MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA FLOW 5F; ISCHEMIC STROKE

Model Number DA5125ST-E

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 02/25/2024

Event Type  Injury  

Event Description

It was reported that the physician was treating a stroke on the right media artery.An aspiration catheter was placed on the proximal thrombus inside the right media artery.A first trial of aspiration was not sufficient.The decision for thrombectomy using a stentriever and microcatheter was made.After the first pass, a positive effect on the media artery was shown.At the same time a thrombus formation at the carotid t was noticed.During the preparation for the second pass, physician noticed a wire coming out of the distal tip of the catheter.The catheter was exchanged to another catheter and the examination continued.When the catheter was advanced physician found an ongoing thrombus formation on the carotid t.The media artery was occluded.The physician had the impression that some material was sheared off from the tip of the previous catheter.It was the physician's opinion that this material was the root cause for the complete occlusion of the carotid t.Several trials of thrombectomy were performed to remove the material and thrombus from the carotid t and media artery.All trials were unsuccessful; the arteries remained occluded.Several lysing agents were given, heparin and agrastat, without positive effect.The patient was reported to be in critical condition.Neurologists, neurosurgeons and neuroradiologists expect a poor outcome if the patient survives.

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 stated to be available for return to the manufacturer for evaluation, but has not yet been returned.However, procedural imaging was provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

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; however, an image of the device after removal from the patient was provided for review.Investigation findings: the provided image of the sofia shows a singular wire strand emerging from the distal tip of the device as described in the reported event.No clear deformation, damage, or sheering/peeling of the outer coating of the catheter could be observed from the provided image; therefore, it cannot be determined if any material fell off of the device and contributed to the alleged vessel occlusion.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.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: vessel or aneurysm perforation, 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¿ catheter to reduce the chance of accidental damage.Use caution when manipulating the sofia¿ catheter in tortuous vasculature to avoid damage.Avoid advancing or withdrawal against resistance until the cause of resistance is determined.Presence of calcifications, irregularities, or other devices may damage the sofia¿ catheter and potentially affect its insertion or removal.Maintain perfusion of heparinized saline for inner lumen of the sofia¿ catheter to prevent thrombus formation.If removed from the patient, the hydrophilic coating on the sofia¿ catheter should be hydrated with heparinized saline.Do not allow the coating to dry.Delivery of the sofia¿ catheter 6.Go to step 7 or 8, depending on the situation described below and choose appropriate devices for navigation of the sofia¿ catheter.7.Navigation through the vasculature, except for the intracranial vasculature c.Using the introducer sheath provided in the package, carefully insert the sofia¿ catheter and the guidewire through a hemostatic valve of the femoral sheath.E.Under fluoroscopic guidance, advance or withdraw the sofia¿ catheter over the guidewire until desired position is attained or before the intracranial position is achieved.Select vessels by slowly torquing the sofia¿ catheter if necessary.Warning: do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Warning: torquing the sofia¿ 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.Warning: do not exceed 2070 kpa (300 psi) maximum recommended infusion pressure.Excess pressure may damage the device or injure the patient.Carefully monitor placement of the distal tip when using a power injector to infuse.F.Go to step 8 for navigation through the intracranial vasculatures.Otherwise proceed to step 9.8.Navigation through the intracranial vasculature c.Under fluoroscopic guidance, advance or withdraw the sofia¿ catheter over the microcatheter and the guidewire until desired position is attained.Select vessels by slowly torquing the sofia¿ catheter if necessary.Warning: do not advance or withdraw the device when excessive resistance is met until the cause of resistance is determined.Warning: torquing the sofia¿ 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.Warning: do not exceed 2070 kpa (300 psi) maximum recommended infusion pressure.Excess pressure may damage the device or injure the patient.Carefully monitor placement of the distal tip when using a power injector to infuse.Aspiration through the sofia¿ catheter with syringe 7.Make sure that the syringe aspirates blood, emboli, or thrombi through the system.Close the stopcock if the syringe does not aspirate any blood, emboli, or thrombi, or slow aspiration is observed.Carefully investigate the cause of the restriction and reposition the distal tip if necessary.If blood, emboli, or thrombi is stuck in the sofia¿ catheter remove the entire device (the device, microcatheter, and guidewire) and clear the inner lumen.If restriction still remains and the distal tip of the sofia¿ catheter has been repositioned correctly, close the stopcock, re-attach the syringe, and resume aspiration.Maintain aspiration to make sure the emboli or thrombi remains fully engaged with the distal tip of the sofia¿ catheter.With the emboli or thrombi fully engaged pull back the sofia¿ catheter out of the patient body.Warning: excessive aspiration with the distal tip of the sofia¿ catheter covered by the vessel wall may cause vessel injury.8.After aspiration is completed, remove the sofia¿ catheter from the patient body.If re-access to the vasculatures with the same device is desired, flush and clean the inner lumen of the device by infusion.Inspect the device for any damage.Follow steps 6 through 9 in the delivery of the sofia¿ catheter section for navigation.Warning: do not use the device if any damages or irregularities are observed.Aspiration through the sofia¿ catheter with pump 3.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.7.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.8.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¿ catheter to engage the thrombus and resume aspiration.9.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¿ catheter.With the thrombus or embolus fully engaged, slowly pull back the sofia¿ catheter and completely withdraw out of the patient.Warning: excessive aspiration with the distal tip of the sofia¿ catheter engaged with vessel wall may cause vessel injury.Procedure/medical information review: imaging review, (b)(6), (b)(6), md, (b)(6) 2024: eleven radiographic images are submitted.They are embedded into a word document.I will be describing them in the order in which they appear.None are labeled as to date or time.Picture1 initial: right ica dsa, lateral, subtracted, contrast, arterial phase.Filling defects seen in the ica terminus, proximal m1 and the m2 segments of the mca, compatible with clot.There is good flow in the aca.There is slow flow in the right mca territory.A sofia catheter is seen with its tip at the level of the ica terminus.Picture2: right ica dsa, ap, subtracted, contrast, arterial phase.Filling defects seen in the ica terminus, proximal m1 and the m2 segments of the mca, compatible with clot.There is good flow in the aca.There is slow flow in the right mca territory.A sofia catheter is seen with its tip at the level of the ica terminus.Picture3: right ica dsa, lateral, subtracted, contrast, arterial phase.The ica is seen only to the level of the terminus and proximal aca and mca.Non occlusive filling defects (likely clot) are seen in the ophthalmic segment.A sofia catheter is again seen with its tip at the level of the ica terminus.Picture4: same as picture2, but the image seems to have been reversed left to right, such that it appears to be the left ica that is being imaged.Picture5: same as picture1.Picture6: right ica dsa, lateral, subtracted, contrast, arterial phase.The ica is seen only to the level of the terminus and proximal aca and mca.Non occlusive filling defects (likely clot) are now seen in the mid cavernous ica; there are none where previously described at the ophthalmic artery level.The sofia catheter is no longer present.Picture7: right ica dsa, ap, subtracted, contrast, arterial phase.Non-occlusive filling defects seen in the mid-cavernous ica,ica terminus, proximal m1, a1 and an occlusive clot is seen in the distal m1 segment of the mca.There is good flow in the aca.There is slow flow in the right mca territory.A sofia catheter is seen with its tip in the cavernous ica.Picture8: same as picture1.Picture9 after embotrap: same as picture6.Picture10: same as picture7.Picture11 end of exam final result: right ica dsa, ap, subtracted, contrast, arterial phase.There is a non-occlusive filling defect in the supraclinoid ica.There are filling defect at the ica terminus that allow flow into the aca, but that have occluded the mca m1 segment at its origin.Concerning the claim that there are pieces of the sofia that broke off and are occluding the blood vessels, i cannot say whether that is the case or not, because the images are all subtracted and would not show metal fragments (they would only be seen on unsubtracted radiographs or a ct scan).

Event Description

Additional information received: patient passed away (b)(6) 2024.The cause of death the total occlusion of carotid and media artery that caused the patients death.

• Brand Name: SOFIA FLOW 5F
• Type of Device: ISCHEMIC STROKE
• 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: 18942314
• MDR Text Key: 338145034
• Report Number: 2032493-2024-00228
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00816777025913
• UDI-Public: (01)00816777025913(11)231130(17)261031(10)0000468655
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DA5125ST-E
• Device Lot Number: 0000468655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2023
• 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: 77 YR
• Patient Sex: Female