MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; CATHETER, THROMBUS RETRIEVER

Catalog Number ET309645

Device Problems Entrapment of Device (1212); Fracture (1260); Retraction Problem (1536)

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

Event Date 02/17/2024

Event Type  Injury  

Event Description

It was reported, via a personal interaction, that an embotrap iii 6.5 mm x 45 mm (et309645/ 23j079av) and an unknown emboguard balloon guide catheter (bg8795u/lot # unknown) were used for a mechanical thrombectomy procedure to treat an occlusion at the ¿internal carotid artery (ica) to m1.¿ during the procedure, the user reported emboguard-tracking difficulty, and embotrap-withdrawal difficulty into guide/intermediate catheter (unable to), device entanglement with other device (eg stent), and strut separation.The event was reported as such, ¿the procedure was a mechanical thrombectomy of internal carotid artery (ica) to m1 occlusion.The ica was severely tortuous, and a precise stent had been implanted to the ica previously.The emboguard was inserted to the patient body and attempted to be delivered beyond the precise stent, but the emboguard could not pass through the stent because the location of the ica was too narrow.The location of the thrombus was confirmed at ica to m1.A mechanical thrombectomy was performed by using embotrap iii and a sofia aspiration catheter.After the embotrap iii was deployed, the stent like assembly of the embotrap iii with the thrombus was attempted to be retracted inside the sofia, but the attempt failed.So, the embotrap iii with the thrombus was pulled to the distal tip of the sofia, and the thrombus was pinched between the embotrap iii and the distal tip of the sofia, and the system was pulled proximally.While pulling the embotrap iii with the thrombus and the sofia.The stent like assembly of the embotrap iii got stuck at the precise stent and could not be pulled.After attempting to pull the embotrap iii, finally the embotrap iii delivery wire moved proximally, but the embotrap iii was damaged and the distal portion of the embotrap iii was remained in the patient vessel, probably caught by the precise stent.The other remining embotrap iii portion was removed outside of the patient body.Thrombus was retrieved by the 1st pass and tici 2b was obtained.The physician commented that angiography was not performed because it probably would not visualize the residual piece of the embotrap iii.An additional precise stent is planned to be implanted inside the existing precise stent.¿ it was further commented, ¿no negative symptoms were observed with the patient.A continuous flush was done.¿.Additional information was received on 08-mar-2024.Summary: the product code for the emboguard balloon guide catheter was received; ¿the product code is bg8795u, the lot number is unknown.¿ this additional device information has been updated in the initial note above.The ica was severely tortuous.Regarding whether the decision to place a second precise stent in the area of ic narrowing was based on any of the events that occurred during the thrombectomy or if the decision was based only on the pre-thrombectomy appearance of the ica narrowing, it was further clarified, ¿placement of an additional precise stent is being considered if restenosis is observed due to the detachment of the embotrap iii at the implanted precise stent.The next angiography is planned to be performed one month later.The angiography after a week of the procedure confirmed that the ica origin where this event occurred was still recanalized without any issues, so no additional treatment was performed at this time.Currently, the distal cone and the next 1 segment of the embotrap iii device is remaining at the implanted precise stet at ica.¿ regarding any patient treatment therapies changed as a consequence of the retained fragment, it was stated, ¿yes, medication duration was changed.The duration of dapt will be extended to 6 months from the initial plan.The physician is planning to administer the same medication as general hemorrhagic treatments.Currently, there is no angiographic findings showing thrombus under the current heparin and dapt treatments.¿ regarding whether it was determined that the stent remnant created any impact vessel patency, it was said, ¿no issues at the timing of 1 week follow-up.The artery is still in the patent state.¿ regarding whether the physician attempted to fully retract the et iii into the sofia and if so, did the physician feel that the inability to pull the et iii completely into the sofia was a device failure or the consequence of firm clot, it was said, ¿yes, the embotrap iii was attempted to be retracted completely inside the sofia, but it failed.The physician thinks that potential cause of this attempt failure is sofia¿s structure.It was known by the physician that sofia is structurally unsuitable on the asap technique which stent retriever is retracted inside an aspiration catheter.¿ it was also disclosed, the ¿inner diameter of the stenosis site of ica was smaller than the od [outer diameter] of emboguard, and this was why the emboguard could not pass through the precise stent.¿ regarding the patient¿s status, ¿the patient is still being hospitalized, but the condition is well.A slight paralysis can be observed, so the patient will transfer to other hospital (i.E.Rehabilitation hospital).¿ the event date was 17-feb-2024.There was no vessel damage due to the event.It is unknown if the event resulted in a procedural delay.Patient information, including past medical history, were not made available at the time of this review.

Manufacturer Narrative

Product complaint #(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1.Initial reporter phone: (b)(6).The device was discarded; therefore, no further investigation can be performed.A review of the manufacturing documentation associated with lot 23j079av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Tracking difficulty and the inability to withdraw the embotrap iii device device into the intermediate/guide catheter after deployment can result in the unintended loss of access to the occluded treatment site, requiring re-access with an increased risk for vasospasm, emboli, vessel damage, ischemia, or infarct, and/or the need for additional intervention.Device entanglement with another device (precise stent) could prevent device retrieval and could cause damage to the device with the potential to result in vessel damage, the release of emboli and subsequent ischemia or infarct, and/or the need for additional intervention.In addition, fracture of a strut on the stent-like cage assembly, with separation (unknown if inner channel or outer cage), can lead to vessel damage, embolization, ischemia, or infarct, and/or the need for additional intervention.It is important to note, the embotrap iii device was not used according to the instructions for use (ifu); per the ifu, the deployed device should not be withdrawn through a previously stented vessel.If it becomes necessary to cross a deployed stent to access a clot, first the user must ensure that the stent can be crossed with the guide or intermediate catheter.The device should then be fully pulled back into guide or intermediate catheter prior to retrieval through the stent.In addition, it is noted in bold that a contraindication for the device is use in a vessel with excessive tortuosity that may prevent device delivery or withdrawal.In this case, the events resulted in damage to the device, and the ¿distal portion of the embotrap iii was remaining in the patient vessel, probably caught by the precise stent embotrap iii.¿ the severity of the event/impact to the patient is unknown at this time.It is unknown if the event will require an additional surgical procedure.It was, however, disclosed that the patient will be prescribed anticoagulation medications for an additional six months, which will require intermittent diagnostic tests for therapeutic effect.Therefore, this event does meet us fda reporting criteria under 21 cfr 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).A medical imaging was reviewed by cerenovus sr.Medical affairs director, dr.(b)(6) (neurointerventionalist), on (b)(6) 2024.The assessment reads as follows: ¿the event description is clear.The complaint is that part of the embotrap iii remained in situ.The physician clearly describes that the receiving catheter (sofia aspiration catheter, microvention) was unable to accept the embotrap iii with clot.This is a known phenomenon due to the softness of the distal portion of this catheter.The embotrap iii/clot was then pinched within the tip of this catheter and the system was removed.This implies that part of the embotrap iii cage remained outside of the catheter.Pulling any deployed stentretriever through a previously placed vascular stent may result in the well-known and recognized hazard of entanglement of the components of each device.Once this situation occurs it may be irreversible despite all maneuvers.Given the fact that stent was placed in the carotid bifurcation, one entanglement occurred, the pulling force generated during stentretriever removal could be sufficient to detach (part of) the embotrap iii from the pusher, either due to manipulation or metal failure.Further analysis of the retrieved segment will give more clarity on what happened.Although it was, as it seems from the description, understandably impossible to avoid the retrieval through the stent, this is usually strongly discouraged due to the known risk of entanglement.¿ a supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EMBOTRAP III 6.5 MM X 45 MM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18886764
• MDR Text Key: 337451367
• Report Number: 3011370111-2024-00019
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: 10886704082859
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K211338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ET309645
• Device Lot Number: 23J079AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2023
• 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
• Treatment: EMBOGUARD 87, 95 CM.; PRECISE¿ CAROTID STENT SYSTEM (CORDIS).; SOFIA¿ ASPIRATION CATHETER (MICROVENTION).
• Patient Outcome(s): Required Intervention