MAUDE Adverse Event Report: MICROVENTION, INC. ERIC 6; ISCHEMIC STROKE

Model Number ER176044-US

Device Problems Retraction Problem (1536); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2023

Event Type  malfunction  

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, 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 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: adverse reaction to platelet/anticoagulation agents or contrast media, air embolism, allergic reactions, angina, arrthymia, arteriovenous fistula, brain edema, coagulopathy, distal embolization including to a previously uninvolved territory, necrosis, nerve damage, pain, vascular occlusion, vision symptoms, 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.Delivery of the eric retrieval device insert the distal end of the introducer sheath into the rhv attached to the microcatheter.Tighten the rhv around the introducer sheath and verify saline flushes back from the proximal end of the introducer sheath.Loosen the rhv and advance the distal end of the introducer sheath until the distal end reaches the end of the hub of the microcatheter.Tighten the rhv around the introducer sheath and make sure there is no bubble observed within the entire system.Gently push the pusher wire of the eric retrieval device into the microcatheter until the distal end of the pusher wire approaches to the proximal end of the introducer sheath.Loosen the rhv and remove the introducer sheath from the pusher wire and tighten the rhv around the pusher wire.Keep pushing the pusher wire until the device exit marker approaches to the rhv.Fluoroscopic guidance must be initiated at this moment.Carefully advance the eric retrieval device until the distal marker of the microcatheter and the distal radiopaque tip of the eric retrieval device are aligned.Note: the distal radiopaque tip of the eric retrieval device is 5mm.Warning: do not advance the eric retrieval device when excessive resistance is observed.Assess the source of resistance using fluoroscopic means.The devices may be damaged and cause injury if the eric retrieval device is advanced.Deployment of the eric retrieval device position the proximal marker to align with the proximal interface of the thrombus to allow for the device to extend beyond the clot.Loosen the rhv around the microcatheter.Withdraw the microcatheter to deploy the eric retrieval device while maintaining the retrieval spheres in the same location.Refer to figure below for device deployment.Note: length of the distal tip is 5mm.Once the eric retrieval device is fully deployed, place the distal tip of the microcatheter close to the proximal end of the retrieval sphere.Tighten the rhv around the microcatheter to fix the system.Retraction of the eric retrieval device make sure that the distal tip of the microcatheter is positioned just proximal to the retrieval spheres.Warning: maintain the distal tip marker in the same position during withdrawal to reduce risk of device fracture.Loosen the rhv around the microcatheter just enough to allow retraction of the microcatheter while maintaining seal for aspiration.Replace saline perfusion line with 60 cc syringe to the side port of the rhv at the proximal end of the guiding catheter.Make sure that the rhv maintains seal within the guiding catheter by applying aspiration using the 60 cc syringe.Adjust the rhv if necessary.Start aspiration to the guiding catheter using the 60 cc syringe and slowly retract the eric retrieval device together with the microcatheter to retrieve thrombus.While maintaining aspiration to the guiding catheter, continue retracting the eric retrieval device and the microcatheter until the retrieval spheres arrive in the proximal end of the guiding catheter.Warning: do not withdraw the eric retrieval device when excessive resistance is observed.Assess the source of resistance using fluoroscopic means.If needed resheath the eric retrieval device with microcatheter and remove the entire system under aspiration.If resistance is encountered during resheathing, stop resheathing and remove the entire system under aspiration.Warning: do not perform more than three (3) retrieval attempts in the same vessel using the eric retrieval device.Open the rhv and remove the eric retrieval device and the microcatheter from the guiding catheter.Aspirate the guiding catheter to make sure inner lumen of the guiding catheter is clear from any thrombus.Replace the 60 cc syringe with saline perfusion line to the side port of the rhv at the proximal end of the guiding catheter.If additional retrieval attempts are desired with the same device, inspect the eric retrieval device for any damage.Do not use the same device if any damage is observed and use a new device.Clean the eric retrieval device using saline.Ensure during cleaning of the eric retrieval device that all foreign components (e.G., clot, fibers) are fully removed before reinsertion.Use extra caution when cleaning the distal tip of the eric retrieval device.Use a microcatheter to navigate the eric retrieval device for subsequent retrieval attempts following the same steps from 1 through 20 above.Warning: do not perform more than three (3) retrieval attempts in the same vessel using the eric retrieval device.Warning: do not apply excessive force to the distal tip of the eric retrieval device when cleaning the device for additional retrieval attempts.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

It was reported that during treating a right m1 stroke with a clot retriever.A microcatheter and a guide catheter were used.After the first pass of the eric the tech cleaned it and tried pulling it back through guide catheter, experienced friction, and the device could not be retracted.The entire system was removed and the case was completed.The physician tried to pull the clot retriever through the guide catheter on the back table and the wire separated from the device.There was no reported harm or injury to the patient.

• Brand Name: ERIC 6
• Type of Device: ISCHEMIC STROKE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16700707
• MDR Text Key: 313044052
• Report Number: 2032493-2023-00651
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00810170018862
• UDI-Public: (01)00810170018862(11)221109(17)271031(10)0000281275
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ER176044-US
• Device Catalogue Number: ERIC176044
• Device Lot Number: 0000281275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2022
• 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 Age: 97 YR
• Patient Sex: Female