MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309645

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

Patient Problem Insufficient Information (4580)

Event Date 09/10/2022

Event Type  Death  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is not available for further investigation as it remains in the patient.A review of the dhr records confirms that there were no issues with the assembly of the lots (sub-assembly and top assembly), all rejects were accounted for during the dhr review.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 4.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.

Event Description

It was reported from a personal interaction that a patient underwent mechanical thrombectomy for an occlusion of the m1 segment of the middle cerebral artery (mca) using a 6.5mm x 45mm embotrap iii (et309645/ 22e052av) revascularization device.Per the event description, the embotrap iii device got separated during the procedure.The physician attempted to remove the separated embotrap iii device with a snare but was unsuccessful as the separated fragment(s) remained inside the patient¿s body.It was claimed that a combined technique was used during the surgery.Other devices used includes a 5fr sofia suction catheter and a trak microcatheter.Continuous flush was performed.No information was reported regarding the patient¿s condition after the surgery.On 27-sep-2022, additional and corrected information was obtained regarding this complaint.The patient is a 67-year-old female with a 40-year smoking history of 10 cigarettes per day and with co-morbidities of hypertension and atrial fibrillation.The date of the surgery when this event happened is (b)(6) 2022.Initial angiography showed a large amount of thrombus at the internal carotid artery (ic) siphon site and m1 occlusion (referred to as tandem lesions).Initially, the ic site thrombus was attempted to be retrieved by the adapt technique using the 5fr sofia aspiration catheter but failed.The physician then decided to perform the combined technique using the 5fr sofia aspiration catheter combined with the embotrap iii device.During the 1st pass, the embotrap iii was deployed at the m1 horizontal area, and a slight thrombus was removed.However, it was noticed that the occluded ic site moved slightly more distal from the original location.No resistance or any abnormality was noted by the physician.During the 2nd pass, the embotrap iii was again deployed at the m1 horizontal area.An attempt was made to deliver the 5fr sofia catheter to the proximal side of the thrombus, however the catheter was unable to advance.The physician then tried to withdraw the embotrap iii without advancing the 5fr sofia catheter, but it was noticed that the embotrap iii device got stuck after it moved slightly proximal from the deployed location (about the length of 2 segments of outer cages).An attempt was made to re-sheath the embotrap iii but failed.While the physician was pulling the embotrap iii proximally, it got detached.The physician attempted to retrieve the detached component using a 4mm and 7mm goose neck snares but failed.After this, another attempt to retrieve using trevo 6-37 retriever was made.The thrombus trapped inside the embotrap iii cages was retrieved, but not the detached component of the embotrap iii.The procedure ended with the detached component left inside the patient.An angiography was performed post-surgery which showed a carotid-cavernous fistula (ccf).It was unknown as to when this occurred.In addition, the imaging confirmed that the proximal coil of embotrap iii was present inside the patient body; however, the exact detached location of the device is unknown.The rest of the device (i.E.Delivery wire) taken out of the patient was discarded without conducting an inspection of the detachment location, hence it cannot be determined if there was any deformation/damage on the embotrap iii device.It was confirmed that there were no noted vessel calcification, stenosis, nor plaques.The physician claimed to have used the device per the ifu.The patient expired on (b)(6) 2022.The accurate correlation between the cause of death and embotrap iii detachment is reported as unknown.Per the physician¿s assessment, the main cause of death was the failure to recanalize the internal carotid artery.There were also other potential factors claimed to have contributed to the patient¿s outcome such as the ¿bad vessel condition¿ and the failed difficult retrieval of the thrombus (via the adapt technique).It was also noted that a large amount of clot/ endodermis was present at the proximal side of the embotrap iii, inside the cages.Per physician¿s assessment, its presence might have caused the failed re-sheathing attempt on the embotrap iii.Hence, the physician is asking advice on any other methods on how to prevent the device from getting stuck and retrieving it once that happens.

Manufacturer Narrative

Product complaint#: (b)(4).Section b5: the imaging submitted with this complaint was reviewed by the cerenovus senior medical affairs director (neurointerventionalist).The review indicated that ¿the description and images provided align with detachment of the et iii device from the pusher wire, with the former being retained within the patient.Detachment of the et iii device from the pusher wire is a rare occurrence.In this case, detachment may have occurred as a result advancement of the aspiration catheter creating malalignment with the et iii device during resheathing.The images pre detachment show the proximal portion of the et iii in the supraclinoid carotid, whereas the markers of the device are more proximal after detachment.The images after detachment show concurrent devices which make interpretation difficult and assessment of the proximal et iii impossible.Based on the description, the event may have occurred due to breakage of the wire or ¿unhooking¿ of the connection point on the device, both as a result of forward pressure on the pusher and device¿.Section e1.Initial reporter phone: (b)(6).Complaint conclusion: it was reported from a personal interaction that a patient underwent mechanical thrombectomy for an occlusion of the m1 segment of the middle cerebral artery (mca) using a 6.5mm x 45mm embotrap iii (et309645/ 22e052av) revascularization device.Per the event description, the embotrap iii (et3) device got separated during the procedure.The physician attempted to remove the separated embotrap iii device with a snare but was unsuccessful as the separated fragment(s) remained inside the patient¿s body.It was claimed that a combined technique was used during the surgery.Other devices used includes a 5fr sofia suction catheter and a trak microcatheter.Continuous flush was performed.No information was reported regarding the patient¿s condition after the surgery.Additional information was received on 27-sep-2022 indicating that the patient is a 67-year-old female with a 40-year smoking history of 10 cigarettes per day and with co-morbidities of hypertension and atrial fibrillation.The date of the surgery when this event happened is on 10-sep-2022.Initial angiography showed a large amount of thrombus at the internal carotid artery (ic) siphon site and m1 occlusion (referred to as tandem lesions).Initially, the ic site thrombus was attempted to be retrieved by the adapt technique using the 5fr sofia aspiration catheter but failed.The physician then decided to perform the combined technique using the 5fr sofia aspiration catheter combined with the embotrap iii device.During the 1st pass, the embotrap iii was deployed at the m1 horizontal area, and a slight thrombus was removed.However, it was noticed that the occluded ic site moved slightly more distal from the original location.No resistance or any abnormality was noted by the physician.During the 2nd pass, the embotrap iii was again deployed at the m1 horizontal area.An attempt was made to deliver the 5fr sofia catheter to the proximal side of the thrombus, however the catheter was unable to advance.The physician then tried to withdraw the embotrap iii without advancing the 5fr sofia catheter, but it was noticed that the embotrap iii device got stuck after it moved slightly proximal from the deployed location (about the length of 2 segments of outer cages).An attempt was made to re-sheath the embotrap iii but failed.While the physician was pulling the embotrap iii proximally, it got detached.The physician attempted to retrieve the detached component using a 4mm and 7mm goose neck snares but failed.After this, another attempt to retrieve using trevo 6-37 retriever was made.The thrombus trapped inside the embotrap iii cages was retrieved, but not the detached component of the embotrap iii.The procedure ended with the detached component left inside the patient.An angiography was performed post-surgery which showed a carotid-cavernous fistula (ccf).It was unknown as to when this occurred.In addition, the imaging confirmed that the proximal coil of embotrap iii was present inside the patient body; however, the exact detached location of the device is unknown.The rest of the device (i.E.Delivery wire) taken out of the patient was discarded without conducting an inspection of the detachment location, hence it cannot be determined if there was any deformation/damage on the embotrap iii device.It was confirmed that there were no noted vessel calcification, stenosis, nor plaques.The physician claimed to have used the device per the ifu.The patient expired on (b)(6) 2022.The accurate correlation between the cause of death and embotrap iii detachment is reported as unknown.Per the physician¿s assessment, the main cause of death was the failure to recanalize the internal carotid artery.There were also other potential factors claimed to have contributed to the patient¿s outcome such as the ¿bad vessel condition¿ and the failed difficult retrieval of the thrombus (via the adapt technique).It was also noted that a large amount of clot/ endodermis was present at the proximal side of the embotrap iii, inside the cages.Per physician¿s assessment, its presence might have caused the failed re-sheathing attempt on the embotrap iii.Hence, the physician is asking advice on any other methods on how to prevent the device from getting stuck and retrieving it once that happens.The imaging submitted with this complaint was reviewed by the cerenovus senior medical affairs director (neurointerventionalist).The review indicated that ¿the description and images provided align with detachment of the et iii device from the pusher wire, with the former being retained within the patient.Detachment of the et iii device from the pusher wire is a rare occurrence.In this case, detachment may have occurred as a result advancement of the aspiration catheter creating malalignment with the et iii device during resheathing.The images pre detachment show the proximal portion of the et iii in the supraclinoid carotid, whereas the markers of the device are more proximal after detachment.The images after detachment show concurrent devices which make interpretation difficult and assessment of the proximal et iii impossible.Based on the description, the event may have occurred due to breakage of the wire or ¿unhooking¿ of the connection point on the device, both as a result of forward pressure on the pusher and device¿.The device is not available for further investigation as it remains in the patient.A review of the dhr records confirms that there were no issues with the assembly of the lots (sub-assembly and top assembly), all rejects were accounted for during the dhr review.Death and device malfunction are known complications associated with the use of the embotrap iii revascularization device and is mentioned in the instructions for use (ifu) as such.According to the information provided, there was difficulty in withdrawing the embotrap iii inside the guide catheter, failure in re-sheathing it and got detached eventually.Embotrap iii¿s detached components required the use of goose neck snares and trevo retriever to obtain these parts left inside the patient but attempts were unsuccessful.Although, the physician assessed the cause of death as not directly related to the study device but more on the failure on ic recanalization, these device issues and the need of requiring reaccess to the target site could result in vessel damage, embolization, ischemia or infarct, and/or the need for additional intervention.Hence, the relationship of the embotrap iii with the patient outcome cannot be excluded at this time.Therefore, this event does meet the mdr reporting criteria.The file will be re-reviewed if additional information is received at a later date.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.

• Brand Name: EMBOTRAP III 6.5 MM X 45 MM
• Type of Device: EMBOTRAP III REVASCULARIZATION DEVICE
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15535978
• MDR Text Key: 301100327
• Report Number: 3011370111-2022-00094
• 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: K193063
• 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: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ET309645
• Device Catalogue Number: ET309645
• Device Lot Number: 22E052AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2022
• 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: 4MM AND 7MM GOOSE NECK SNARES.; 5FR SOFIA SUCTION CATHETER.; TRAK MICROCATHETER.
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Sex: Female