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

Catalog Number ET309645

Device Problems Retraction Problem (1536); Material Separation (1562); Stretched (1601)

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

Event Date 07/09/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a mechanical thrombectomy procedure to treat an acute ischemic stroke with the target occlusion being ¿a quite solid and long thrombus¿ from the internal carotid artery (ica) to the distal m1 (m1d) segment of the middle cerebral artery (mca), a 6.5mm x 45mm embotrap iii revascularization device (et309645 / 23b154av) was deployed at the origin of the m2 as usual; an embovac large bore catheter (ic71132ca / 31041010) was then inserted to attempt for clot retrieval.It was reported that the embotrap iii device became stuck and would not move at all.The physician tried to push and pull it, but the embotrap would not move.The embovac could not insert close to it, and during the attempt to resheath, the microcatheter a phenom¿ microcatheter (medtronic) could not insert into the embotrap either.After adjusting the position of the guiding catheter, the microcatheter got close to it and eventually was able to retrieve the embotrap iii.Recanalization could not be achieved.After the embotrap iii device was retrieved from the patient¿s anatomy, the stent component was separated from the shaft when it was slightly touched.The embovac was stretched and the surface was scratched at 10cm from the catheter tip.Continuous flush was maintained during the procedure.There was no report of any negative patient impact.On 27-jul-2023, limited additional information was received.Per the additional information, the reported issue with the embotrap iii device becoming stuck was encountered on the first pass.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of the manufacturing documentation associated with this lot (23b154av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.Investigation summary: the embotrap device was returned in two components: the nitinol shaft and the distal assembly (inner channel, outer cage, and distal coil).Visual examination of the returned embotrap device confirmed that damage and deformation was evident on the proximal and body segments of the device, and on both proximal and distal coils.The adhesive proximal bond and proximal joint were not intact.Detachment of the distal stent portion of the device from the proximal shaft portion of the returned embotrap device was evident.There are three aspects to the complaint event, described in the sections above and summarized below: 1) embotrap was ¿stuck and would not move at all¿ after deployment in the m2 vessel.Recreation of this aspect was not possible, and this aspect of the complaint event could not be confirmed.However, potential root cause is an interaction between the stent portion of the device and a particularly challenging occlusion (the ¿quite solid and long thrombus from ica to distal m1¿).2) inability to advance the embovac aspiration catheter and microcatheter towards the embotrap, and damage to the embovac.Recreation with the sample devices did not result in inability of the embovac aspiration catheter to advance nor of the microcatheter to re-sheath the embotrap while the latter is stuck in the anatomy.Also, the damaged embovac was not returned, and the stretched shape and scratch cannot be confirmed.Therefore, this aspect could not be confirmed.However, potential root cause for this aspect of the complaint is tortuous anatomy (¿severe bend¿ between ica and m1) and lack of support by the guide catheter (the physician was able to readvance the microcatheter and retrieve the embotrap after repositioning the guide catheter).3) distal stent assembly detachment post procedure and damage to the outer cage struts and coils.The device was returned disassembled; therefore, this aspect of the complaint is confirmed.It was reported that after getting stuck in the anatomy the embotrap was subject to a ¿push and pull¿ manoeuvre.By attempting to advance the device in a deployed state, the proximal bond and mechanical lock at the proximal joint are subjected to compressive force, potentially applying pressure to the proximal bond, and weakening the integrity of the proximal joint.Recreation of this aspect with sample devices showed that by attempting advancement and withdrawal of a deployed embotrap while stuck in the anatomy may result in damage to the embotrap device.The proximal bond lost its integrity, and the proximal joint was not intact.Whilst this aspect of the complaint is confirmed, the extent of damage to the embotrap device could not be recreated.The potential root cause is push and pull forces applied to the device while stuck in the anatomy, however, the root cause could not be determined.A review of the manufacturing documentation associated with this lot (23b154av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.Investigation conclusion: the embotrap device was returned disassembled (distal stent assembly detached from the nitinol shaft) therefore the main aspect of the complaint is confirmed.Damage/deformation was present on the cage and both proximal and distal coil.The associated accessories (embovac and microcatheter) were not returned therefore damage to the embovac could not be confirmed.The event description indicates that the embotrap device a got stuck in the anatomy after deployment.The device instructions for use (ifu) warns against advancing the deployed device or withdrawing against significant resistance.In case of resistance, the ifu indicates to ¿assess the cause of resistance using fluoroscopy and, if necessary, advance the microcatheter over the device to re-sheath or partially re-sheath to aid withdrawal.¿ in the reported event, re-advancement of the microcatheter and re-sheathing was initially unsuccessful, until repositioning of the guide catheter.Before repositioning of the guide catheter and completion of microcatheter re-advancement and device retrieval, the embotrap device was subject to push and pull maneuvers which may have caused or contributed to some of the damages (deformation of struts) observed to the device and the detachment of the distal stent assembly.While the main aspect of the complaint event (detachment of the embotrap device outside the patient¿s body) is confirmed, the root cause could not be determined.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2023-00083 and 3008114965-2023-00653.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 21-aug-2023.[additional information]: on 21-aug-2023, additional information was received.The information indicated that there was a severe bent from the internal carotid artery (ica) to the middle cerebral artery (mca).The embotrap iii device made only one (1) pass.The physician did not apply extra force more than necessary to the device against resistance.The information indicated that there was no additional interventions.There was no device-related events to the patient; the patient¿s condition is reported to be unknown.The thrombus was not completely removed.The information indicated that the procedure was completed without additional measures.There was no issues with the advancement of the embovac device, but during withdrawal, there was resistance felt around the m1.Care was taken not to apply excessive force to the device during the procedure.The embovac was not replaced.The information indicated that there was delay after the embotrap iii device was stuck, however, the duration of the delay and the any possible clinical impacts are not known.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 08-aug-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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 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 ; 303552-689
• MDR Report Key: 17414690
• MDR Text Key: 319963899
• Report Number: 3011370111-2023-00083
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ET309645
• Device Lot Number: 23B154AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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: IC 71, 132 CM, CE, ASP. IND.; PHENOM¿ MICROCATHETER (MEDTRONIC).