MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Catalog Number ET007533

Device Problem Difficult to Remove (1528)

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

Event Date 03/24/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).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.

Event Description

The healthcare professional reported that the embotrap ii revascularization device (unknown product code and lot number) was getting stuck on clot retrieval in the right m1 segment-ica (internal carotid artery) junction.It was reported that the physician was able to withdraw the embotrap device.There was no report of any patient adverse event or patient complication associated with the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 22 july 2021.[additional information]: the healthcare professional reported that the embotrap ii revascularization device (unknown product code and lot number) was getting stuck on clot retrieval in the right m1 segment-ica (internal carotid artery) junction.It was reported that the physician was able to withdraw the embotrap device.There was no report of any patient adverse event or patient complication associated with the reported issue.On 22 july 2021, additional information was received.The procedure was on 24 march 2021.The sequence of event that led up to the withdrawal difficulty is as following: the patient was last seen well at 11:00 hour.Left hemiplegia, gaze deviation to the right, mildly dysarthric.No dysphasia.Nihss 18 as per the stroke team.Aspects 9 (insula), right terminal internal carotid artery (ica) occlusion but t junction is patent.Tandem right distal m1 occlusion.Thrombolysis done.¿under us¿ and 8fr sheath was introduced in the left common femoral artery (cfa) at 14:46 hour.The 8 fr flowgate2¿ balloon guide catheter (stryker) ¿over a 6 fr mp catheter and a terumo combination was placed in the right cervical ica just below a tonsillar loop.¿ digital subtraction angiography (dsa) demonstrated a right ica distal occlusion, distal to the origin of the right posterior communicating artery (pcomm).The thrombolysis in cerebral infarction (tici) was 0.The first pass (14:59 hour): the balloon was inflated and aspiration from the guide catheter was attempted.This resulted in a small amount of clot, but no angiographic improvement.Tici 0.An axs catalyst® 7 catheter (stryker) was advanced in the right ica; it passed the tonsillar loop but did not reach the thrombus.A.025 velocity® delivery microcatheter (penumbra) and a traxcess® guidewire (microvention-terumo) was placed in a right m2 branch.The second pass (15:43 hour), a 5mm x 33mm embotrap ii revascularization device (et007533 / 20j128av) was used in combination with aspiration.When the physician was attempting to retrieve the embotrap ii inside the velocity microcatheter, it got trapped in the middle cerebral artery (mca) / ica shoulder and could not be retrieved.The physician removed the velocity microcatheter and tried to retrieve the embotrap ii device inside the catalyst, which ¿did the trick¿ after a ¿give away¿ sensation.There were several segments of fragmented thrombus were present in the embotrap stent retriever and aspiration syringe.Tici was 3.It was reported that the embotrap ii was trapped inside the right mca/ica junction, but the physician is not sure of the cause.The embotrap ii device did not appear damaged in anyway after it was removed.There was continuous flush maintained through the velocity microcatheter.The second pass, the pass in question when the withdrawal difficulty issue was encountered took 44 minutes; however, this delay was not considered clinically significant.There was no evidence of thromboembolism due to the reported withdrawal difficulty issue.On (b)(6) 2021, the treating physician, cerenovus principal research engineer, and the sales representative team met via teleconference.The discussion took place from 4 pm to 4:45 pm local ireland / uk time.The physician described the case: it was an ica-t / m1 occlusion.The first pass was remote aspiration through the 8 fr.Flowgate balloon guide catheter (bgc), a small amount of clot removed, but no angiographic improvement, tici 0.A cat-7 was introduced but did not reach thrombus due to tortuosity.An.025 velocity microcatheter and traxcess microwire was placed in a right m2 branch.Embotrap ii 5 x 33 was deployed.The proximal part of the device was right at the junction of ica-m1, such that the device and velocity made a very acute angle.In the first pass, the physician tried to retrieve the device but was ¿stuck¿ and would not move.The physician tried to re-sheath with velocity, but it wouldn¿t resheath at all.The physician described her concern that the pusher wire was detached from the device.So, she carefully removed the velocity.025 microcatheter, and advanced the cat-7 closer to the clot.Then when trying to retrieve there was a ¿give away¿ sensation that allowed her to pull the device into the catheter.Upon inspection, nothing obvious in the device or the clot for the physician to explain this concern.The physician commented that she has not experienced this with any other device.She believes it has to do with the proximal end of the device not being designed for smooth withdrawal.During this discussion, the concern was acknowledged, we shared the low rate of complaint difficulty, and we also shared in the literature the typical causes can also include angle of interaction and clot type.The physician confirmed that the angle of interaction was very acute, and probably why it retrieved easily when cat-7 was positioned closer to the clot.However, her complaint is that this should not have happened in the first place as it does not happen with other devices.She did not save the embotrap ii device to be returned for evaluation and analysis.No images were provided.Based on complaint information, the device was not available to be returned for analysis.A review of the device history records (dhr) confirms that there were no issues with the assembly of the lot 20j128av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Withdrawal difficulty from vessel is a well-known potential procedural complication associated with the embotrap revascularization device.The ifu also warns the user to not withdraw the device against significant resistance.The root cause of the event cannot be conclusively determined based on the information available for review.However, there are clinical and procedural factors, including clot burden, vessel characteristics, device selection, and operator technique, that may have been factors that contributed to the reported issue rather than the design or manufacture of the device.The additional information received indicated that the case was an ica-t / m1 occlusion, a catalyst® 7 catheter (stryker) was advanced in the right ica; it passed the tonsillar loop but did not reach the thrombus due to tortuosity; and as captured in the teleconference, the physician did confirm that the angle of interaction was very acute which likely was the reason once the cat-7 was positioned closer to the clot, the embotrap ii device was easily retrieved into the cat-7.Withdrawal difficulty from vessel meets mdr reporting criteria as a malfunction as it could result in vessel trauma, vessel spasm, damage to the basket with the potential for release of emboli and subsequent ischemia or infarct, and/or the need for additional intervention.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.Updated sections: b.3, d.1, d.4, e.1, e.3, g.3, g.6, h.2, h.3, h.6, h.10, and concomitant products.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 II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 12194147
• MDR Text Key: 262640845
• Report Number: 3011370111-2021-00053
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2023
• Device Catalogue Number: ET007533
• Device Lot Number: 20J128AV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 6 FR MP CATHETER (UNKNOWN BRAND); AXS CATALYST® 7 CATHETER (STRYKER); FLOWGATE2¿ BALLOON GUIDE CATHETER (STRYKER); TRAXCESS® GUIDEWIRE (MICROVENTION-TERUMO); VELOCITY® DELIVERY MICROCATHETER (PENUMBRA)