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

Catalog Number ET307645

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 01/02/2023

Event Type  Injury  

Event Description

It was reported from that a patient underwent endovascular mechanical thrombectomy using a 6.5mm x 45mm embotrap iii revascularization device (et307645/22f028av) for an occlusion at the left internal carotid artery (ica).Details of the procedure: a neuron max guide catheter was introduced up to the c1 segment of the ica and an ace 68 aspiration catheter was placed inside it, up to the proximal part of the thrombus.A 3max catheter was positioned at the distal part of the thrombus for the release of the embotrap.The preparation, purging, and transition of the embotrap iii stent to the microcatheter was performed correctly.It was referred that when the stent was raised through the microcatheter to place it at its distal tip, the doctor noticed that the stent is not progression through the vasculature.With the help of fluoroscopy, the stent was observed to be in in the microcatheter at the descending aorta.Given the situation, the embotrap iii stent was removed in its sleeve and released outside the patient to observe its condition.At this point a damage was observed in the proximal part of the device, which has been said, that prevented the doctor from giving sufficient support to progress the stent through the microcatheter.The physician decided to remove the embotrap iii stent and replace it with a stent from another brand.Reportedly the procedure has been rescheduled.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.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.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 company is seeking this information through the event investigation.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #(b)(4).The initial examination of the returned embotrap device identified evidence of damage on the proximal section of the outer cage and inner channel of the device.Kinking of the proximal struts was observed, and this kinking resulted in deformation of the overall shape of the proximal section of the device.Deformation was also observed locally on the inner channel at body section 1 of the device, and on the floating crowns of the outer cage at body sections 1 and 2.No further damage or deformation of the device was observed.The visual inspection also indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The ptfe insertion tool was dimensionally inspected and found to be within specification for the inner and outer diameter.The returned embotrap device was successfully passed through a 0.0195¿ id tube, confirming that the profile of the device conforms to the specification for compatibility with 0.021¿ ¿ 0.027¿ microcatheters.Delivery assessments were carried out with the returned embotrap device and a sample embotrap device, sample 3max reperfusion catheters, and sample 0.021¿ microcatheters.A sample undamaged embotrap device could not be delivered through the full length of a sample 3max reperfusion catheter.Under examination it was determined that the embotrap device fails to deliver within the catheter at a region where the od of the catheter decreases.The nature of this transition is unclear (i.E., gradual taper vs step change), but it appears that there is a transition point which acts as a stopping point when attempting to deliver the embotrap device from the proximal side of this transition point.This was demonstrated through backloading of the sample embotrap device and successful advancement and retraction of the device within the 3max catheter distal of this transition point (i.E., the embotrap device can be successfully delivered or retracted once it does not need to pass through this transition point).When the sample embotrap device was retracted from the distal side of this transition point, to the proximal side of this transition point, it failed to deliver distally again, indicating that the transition point causes the embotrap device to fail to deliver.An additional sample 3max catheter was also tested, with the same results, indicating this was not a result of a defect.The complaint event description stated that the device appeared to deliver to a certain point (¿the sheathed stent can be observed from normal way in the microcatheter in the area of the descending aorta¿); it is possible that this was the physician observing the embotrap device meeting this transition point in the 3max catheter during the complaint event.A sample embotrap device was advanced against this point of resistance, resulting in damage of the proximal struts of the sample device similar to those observed on the returned device.During this advancement it felt as if there was advancement of the device following the initial failure to advance once it met the point of resistance.This advancement felt like the shaft and proximal section of the device were advancing due to the application of high force, but the remainder of the device was remaining in place.This feeling was likely the proximal struts of the device kinking as the shaft advanced while the majority of the device remained in place.This was evident as damage of the proximal struts on the device following removal from the catheter.The embotrap iii device is indicated for use with 0.021¿ ¿ 0.027¿ microcatheters.The 3max has a distal inner diameter of 0.035¿, which is outside of this range.The embotrap device is in a partially expanded state when delivered through a catheter with an inner diameter larger than the recommended range.The returned embotrap device was attempted to be delivered with a sample 0.021¿ microcatheter.The returned embotrap device, in it¿s returned damaged state, was successfully delivered to the distal tip of a sample prowler select plus microcatheter.Conclusion: the returned embotrap device shows evidence of damage on the proximal section of the outer cage and inner channel of the device.Visual inspection of the device indicated no further damage or deformation on the device.The 3max reperfusion catheter used during the complaint event could not be inspected as it was not returned.The complaint event states that the embotrap was delivered through a 3max reperfusion catheter which has a distal id of 0.035¿, which is larger than the compatible microcatheter id stated in the embotrap ifu (0.021¿ ¿ 0.027¿).Delivering an embotrap in a catheter with an id larger than 0.021¿ ¿ 0.027¿ will result in delivering the embotrap device in a partially expanded state.In this expanded state, the cells of the outer cage are partially open, creating possible snag points during delivery.During this investigation it was found that a sample embotrap device would not deliver past a certain point of a sample 3max catheter.This point is within a region where the od of the catheter decreases, indicating that the embotrap device is getting stuck in a transition point, where the id decreases.Based on the assessment carried out as part of this investigation, there appears to be a number of contributing factors to the cause of this complaint event.Firstly, the embotrap device was delivered through a catheter with a larger id than that recommended in the embotrap ifu (0.021¿ ¿ 0.027¿).This results in the embotrap device being delivered in a partially expanded state.Secondly, there appears to be a transition point in the 3max catheter, which causes resistance when delivering the embotrap device.The fact that the embotrap is in a partially expanded state potentially contributes to the resistance felt at this transition point.Thirdly, attempting to advance the embotrap device against resistance under these conditions has been demonstrated to cause damage similar to that observed on the returned device.The partially expanded state of the embotrap device may also be contributing to the damage caused when advancing against resistance.The returned device in its current damaged state was shown to conform to the profile of a 0.021¿ microcatheter and was successfully delivered to the distal tip of a sample 0.021¿ microcatheter.There is no indication that this complaint was as a result of a defect or malfunction of the embotrap device.Damage of the device during use is a well-known potential complication associated with the use of the embotrap iii in mechanical thrombectomy procedures and is listed in the instructions for use (ifu) as such.The ifu also warns the user to the possibility of device malfunction or fracture and to the need of device inspection before use the device and to not use a damaged or kinked device.It also states that the device should be introduced through a microcatheter with an id of 0.021¿-0.027¿.Proximal coil - kinked/bent is considered an mdr reportable malfunction as a kinked proximal coil has there is a potential for vessel endothelial lining damage.Therefore, this event is considered serious and mdr reportable.The complaint will be reassessed if additional information becomes available.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Section b5: additional information was received on 31-jan-2023.Summary of relevant additional information provided: it was confirmed that a 3max reperfusion catheter 0.035¿ (.89mm) distal internal diameter (id) was used to deliver the embotrap.It was also clarified that the procedure lasted 15-20 min and continue with another stent retriever ¿ a solitaire 6x40 mm (medtronic) ¿ and that the same microcatheter was used without any issue.The device presented the following damage: a kink in the proximal part of the stent.With the recently provided information section h6.Medical device problem code was updated to ¿material twisted / bent¿ and the health effect ¿ impact code was updated to ¿prolonged surgery¿.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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: 16224407
• MDR Text Key: 307905007
• Report Number: 3011370111-2023-00008
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ET307645
• Device Lot Number: 22F028AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2022
• 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
• Treatment: 3MAX CATHETER; ACE 68 ASPIRATION CATHETER; NEURON MAX GUIDE CATHETER
• Patient Outcome(s): Hospitalization
• Patient Sex: Male