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

Model Number ET009533

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)

Patient Problems Intracranial Hemorrhage (1891); Ischemia Stroke (4418)

Event Date 05/10/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the health care professional reported that the patient underwent a mechanical thrombectomy procedure that was targeting a distal left m1 occlusion using the 5mm x 33mm embotrap ii revascularization device (et009533 / 19m037av) and the marksman¿ microcatheter (medtronic).A guiding catheter only reached to the distal common carotid artery (cca) due to tortuous vasculature and an axs catalyst® aspiration catheter (stryker) was only able to reach the middle of the m1 segment of the middle cerebral artery (mca).There was severe vessel tortuosity from the middle of the m1 segment to the m2 segment.During stent placement, images of the revascularization were obtained, but there was strong resistance felt at the time of stent retrieval.Since the aspiration catheter did not reach the desired location ¿where it was caught,¿ it was slowly pulled back.A percutaneous transluminal angioplasty (pta) procedure was performed using the embotrap ii device, the trevo® retriever (stryker) was also used but only a partial recanalization of the blood vessel was confirmed by pta.It was reported that the patient developed a slight subarachnoid hemorrhage (sah) and an infarction occurred in about half of the affected area.The patient experienced severe aphasia and paralysis.The physician attributed the tortuous vasculature making it difficult to reach the desired location for aspiration, and the hard thrombus as contributing factors to the reported events.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (19m037av) 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.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.Cerebral infarction and subarachnoid hemorrhage are known potential complications associated with the embotrap revascularization device.The patient suffered severe aphasia and paralysis secondary to the cerebral infarction.The root cause of the cerebral infarction and sah events could not be determined based on the available information and without procedural films to review; however, clinical and procedural factors including clot burden / characteristics, vessel characteristics, tortuosity, device selection, and operator technique are all factors that may have contributed.Since the severity of the sah is unknown, the infarction resulted in severe aphasia and paralysis, and the relationship of the device to the reported events cannot be excluded, the event meets mdr reporting criteria.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.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.

Event Description

The health care professional reported that the patient underwent a mechanical thrombectomy procedure that was targeting a distal left m1 occlusion using the 5mm x 33mm embotrap ii revascularization device (et009533 / 19m037av) and the marksman¿ microcatheter (medtronic).A guiding catheter only reached to the distal common carotid artery (cca) due to tortuous vasculature and an axs catalyst® aspiration catheter (stryker) was only able to reach the middle of the m1 segment of the middle cerebral artery (mca).There was severe vessel tortuosity from the middle of the m1 segment to the m2 segment.During stent placement, images of the revascularization were obtained, but there was strong resistance felt at the time of stent retrieval.Since the aspiration catheter did not reach the desired location ¿where it was caught,¿ it was slowly pulled back.A percutaneous transluminal angioplasty (pta) procedure was performed using the embotrap ii device, the trevo® retriever (stryker) was also used but only a partial recanalization of the blood vessel was confirmed by pta.It was reported that the patient developed a slight subarachnoid hemorrhage (sah) and an infarction occurred in about half of the affected area.The patient experienced severe aphasia and paralysis.The physician attributed the tortuous vasculature making it difficult to reach the desired location for aspiration, and the hard thrombus as contributing factors to the reported events.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 26 february 2021.[additional information]: the health care professional reported that the patient underwent a mechanical thrombectomy procedure that was targeting a distal left m1 occlusion using the 5mm x 33mm embotrap ii revascularization device (et009533 / 19m037av) and the marksman¿ microcatheter (medtronic).A guiding catheter only reached to the distal common carotid artery (cca) due to tortuous vasculature and an axs catalyst® 6 aspiration catheter (cat6) (stryker) was only able to reach the middle of the m1 segment of the middle cerebral artery (mca).There was severe vessel tortuosity from the middle of the m1 segment to the m2 segment.During stent placement, images of the revascularization were obtained, but there was strong resistance felt at the time of stent retrieval.Since the aspiration catheter did not reach the desired location ¿where it was caught,¿ it was slowly pulled back.A percutaneous transluminal angioplasty (pta) procedure was performed using the embotrap ii device, the trevo® retriever (stryker) was also used but only a partial recanalization of the blood vessel was confirmed by pta.It was reported that the patient developed a slight subarachnoid hemorrhage (sah) and an infarction occurred in about half of the affected area.The patient experienced severe aphasia and paralysis.The physician attributed the tortuous vasculature making it difficult to reach the desired location for aspiration, and the hard thrombus as contributing factors to the reported events.On 26 february 2021, additional information was received.The information indicated that the patient had severe tortuosity of the middle cerebral artery, and the unspecified guiding catheter could only be advanced to the distal part of the common carotid artery.The cat6 aspiration catheter could only be advanced to the m1 segment of the mca.The marksman microcatheter was delivered to the target position and the embotrap ii device introduced and deployed.Recanalization of the occluded vessel was confirmed via imaging; however, when the physician attempted to withdraw the embotrap ii device, strong resistance was encountered.The device became caught on the clot during retrieval.The physician tried to deliver the aspiration catheter distal to the embotrap ii device to resolve the resistance, but due to the severe vessel tortuosity, this was not possible.The embotrap ii device was then slowly removed from the patient.Thrombolytic therapy was injected and a partial recanalization was visualized.Half of the clot remained in the vessel.A ¿slight¿ subarachnoid hemorrhage occurred post-operatively.The additional information also indicated that the symptoms of aphasia and paralysis were present at baseline, but no information was provided regarding the change in severity or patient outcome.The physician felt that the events were related to the severe vessel tortuosity and the hard thrombus.Withdrawal difficulty from vessel and hemorrhage are known potential complications associated with the use of the embotrap ii revascularization device in endovascular mechanical thrombectomy.The embotrap instructions for use (ifu) warns the user to never withdraw the device against significant resistance.Assess the cause of resistance using fluoroscopy and if necessary, advance the microcatheter over the device to resheath or partially resheath to aid withdrawal.With the amount of information available and without films of the event, it is not possible to draw a conclusion between the device and the reported event.However, there are clinical, procedural, and pharmacological factors, including vessel characteristics, severe tortuosity, clot burden/characteristics, device interaction, device selection, operator technique, and thrombolytic drugs, that may have contributed to the event rather than the design or manufacture of the device.There was no report of vessel injury or trauma that may have been a source of the hemorrhage.The alleged failure of withdrawal difficulty from vessel 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.In addition, the patient suffered from a post-operative subarachnoid hemorrhage where the relationship of the device cannot be excluded based on the available information.Therefore, this event meets mdr reporting criteria.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: 11167932
• MDR Text Key: 230462889
• Report Number: 3011370111-2020-00101
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• 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: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2022
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 19M037AV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AXS CATALYST® 6 CATHETER (STRYKER); MARKSMAN¿ MICROCATHETER (MEDTRONIC); TREVO® RETRIEVER (STRYKER)
• Patient Outcome(s): Life Threatening