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

Model Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intracranial Hemorrhage (1891)
Date of Event	03/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part and lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded and not available for return to the manufacturer for analysis; however, medical notes were provided and are being reviewed part of ongoing investigation.A supplemental report will be submitted once investigation is completed.The instructions for use (ifu) identifies intracerebral/intracranial hemorrhage as a potential complication associated with the use of the device.
Event or Problem Description
As reported through the sofast clinical study, the next day following mechanical thrombectomy procedure that used the sofia aspiration catheter, the patient experienced a subarachnoid hemorrhage noted on ct of the head and described as mild, asymptotic, no change in nihss.Th patient was administered iv heparin, intra-arterial tpa and resolved with sequelae.The event is assessed as possibly related to the sofia device, definitely related to the mechanical thrombectomy procedure, and possibly related to the study disease and concurrent condition/treatment.
Additional Manufacturer Narrative
Summary of investigation: 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.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.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: 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: a medical note review was performed.Review of data indicates that the medical note data is dated (b)(6) 2023.As part of the sofast clinical study, a mechanical thrombectomy procedure was performed with the utilization of a sofia 6f aspiration catheter device on (b)(6) 2023.On (b)(6) 2023, reported postoperative day one, the patient experienced a reported subarachnoid hemorrhage throughout the left frontal parietal region and extending into the left basal cistern which was confirmed by ct imaging.Thrombectomy procedure was reported as completed successfully with resolution of sah with patient discharged to home on (b)(6) 2023 with physical therapy and occupational therapy prescribed.Based on the review, the sah is possibility related to the use of the sofia device which cannot be ruled out, and the sah is identified as related to the performance of the thrombectomy procedure.However, no device malfunction was reported and /or no device malfunction was reported as associated with or contributing to the reported sah.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.

• Brand Name: SOFIA FLOW PLUS 6F
• Common Device Name: 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: 18166010
• Report Number: 2032493-2023-01058
• Device Sequence Number: 20636808
• Product Code: NRY
• UDI-Device Identifier: 00842429108482
• UDI-Public: (01)00842429108482(11)230110(17)251231(10)0000307038
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K173200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Model Number: UNKNOWN
• Device Lot Number: 0000307038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2023
• Supplement Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown