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

Model Number DA6125ST

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 11/03/2022

Event Type  Injury  

Event Description

As reported for a patient enrolled in the sofast study that a thrombectomy procedure was performed with a sofia after collapsing at home with new onset right-sided weakness, dizziness, and aphasia on (b)(6) 2022.He had nasal gauze in place with mild nasal bleeding that is reportedly from a previous sinus procedure.Pre-procedure modified tici score (mtici) was 0.The patient¿s nihss: 15, pre-morbid mrs: 0, and the target vessel was the left middle cerebral artery (mca) m1.Under fluoroscopic roadmap control, a sofia catheter was introduced.After a single aspiration attempt, successful recanalization with mtici of 3 was achieved.At 24 hr.Follow up nihss improved to 0, mrs was 4.During a follow up ct on (b)(6) 2022, a new small volume left sylvian subarachnoid hemorrhage was found, as well as subtle hypoattenuation in the left caudate and lentiform nucleus.The patient was transferred to the floor on (b)(6) 2022, and was easily arousable to voice and reported a mild generalized headache that had been ongoing this hospital stay.No changes in vision or paresthesia, with no chest pain or shortness of breath, and the gauze packing under his nose remained dry.On (b)(6) 2022, the patient had an mri, and no hemorrhage was noted and was resolved without sequelae, and aspirin was started.At 7 day follow up on (b)(6) 2022, the patient¿s nihss was 1, mrs was 3.No bleeding noted, and the patient was discharged to home.At 90 day follow up visit on (b)(6) 2023, the patient¿s nihss was 0 and mrs was 1, and the patient was exited from the study the same day.The site reported the subarachnoid hemorrhage as non-serious, mild, related to procedure, possibly related to the sofia device, not related to study disease or concurrent condition, with outcome of resolved without sequelae on (b)(6) 2022.

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 discarded at the user facility and not returned to the manufacturer for evaluation; however, medical/procedural notes were provided.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.

Manufacturer Narrative

Investigation findings: 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.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.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 torquing 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: torquing 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: torquing 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.Procedure/medical information review: a detailed medical note review has been performed.As part of the sofast study, data review indicates that a thrombectomy procedure was performed with utilization of a sofia device on (b)(6) 2022 which is the date of the index procedure.Data review further indicates that the suspected etiology of the diagnosed stroke was associated with patient stoppage of administration of prescribed asa (acetylsalicylic acid) prior to scheduled sinus surgery.Data review indicates that the patient reported resuming asa on (b)(6) 2023 but developed bleeding and stopped asa again on (b)(6) 2023 with reported stroke occurring on (b)(6) 2023 as stated.On post-operative day one ((b)(6) 2023), the patient experienced the reported ae (small volume left subarachnoid hemorrhage).Assessment of ae outcome data indicates that upon review of post-procedure ct scan data of the head region without contrast, there were no acute intracranial hemorrhage or defined evidence of acute/subacute territorial infarct.Reporting data also indicated successful mechanical thrombectomy of the left middle cerebral artery with restoration of antegrade flow through the m2-m4 branches.Based on the review and medical opinion, there is possible relationship with the reported ae (small volume left subarachnoid hemorrhage) to the sofia device which cannot be ruled out.Medical note data reviewed does not indicate any occurrence of a device malfunction and/or does not indicate any device malfunction that occurred and its association with the reported ae.Further, upon medical review of the presented medical note data, there is no new or significant information that would change the event as reported.Investigation conclusion: a medical note review was performed.As part of the sofast study, data review indicated that a thrombectomy procedure was performed with utilization of a sofia device on (b)(6) 2022 which is the date of the index procedure.Data review further indicated that the suspected etiology of the diagnosed stroke was associated with patient stoppage of administration of prescribed asa (acetylsalicylic acid) prior to scheduled sinus surgery.Data review indicated that the patient reported resuming asa on 29october2023 but developed bleeding and stopped asa again on (b)(6) 2023 with reported stroke occurring on (b)(6) 2023 as stated.On post-operative day one ((b)(6) 2023), the patient experienced the reported ae (small volume left subarachnoid hemorrhage).Assessment of ae outcome data indicated that upon review of post-procedure ct scan data of the head region without contrast, there were no acute intracranial hemorrhage or defined evidence of acute/subacute territorial infarct.Reporting data also indicated successful mechanical thrombectomy of the left middle cerebral artery with restoration of antegrade flow through the m2-m4 branches.Based on the review, there is possible relationship with the reported ae (small volume left subarachnoid hemorrhage) to the sofia device which cannot be ruled out.However, the medical note data reviewed did not indicate any occurrence of a device malfunction and/or does not indicate any device malfunction that occurred and its association with the reported ae.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.

Event Description

Please see section h10 for investigation conclusion.

• Brand Name: SOFIA FLOW PLUS 6F
• Type of Device: PERCUTANEOUS CATHETER
• 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: 18222242
• MDR Text Key: 329196775
• Report Number: 2032493-2023-01078
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00842429108475
• UDI-Public: (01)00842429108475(11)220902(17)250831(10)0000254476
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150366
• 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,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DA6125ST
• Device Lot Number: 0000254476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male