MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 22 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Catalog Number ET307522

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 09/29/2022

Event Type  Death  

Event Description

As reported via the excellent study, an 82-year-old female (subject (b)(6)) with a history of diabetes, hyperlipidemia, and hypertension presented with a stroke on an unknown date.The first symptoms were observed on (b)(6) 2022 and the patient presented to the hospital on the same day.Intravenous tissue plasminogen activator (tpa) was not administered at the time of stroke presentation.The suspected origin of the embolism was a pancreatic carcinoma.The patient¿s baseline nihss score was 12, and the mrs score was 0.The patient underwent an endovascular mechanical thrombectomy using a 5mm x 22mm embotrap iii (et307537/22d064av) device on (b)(6) 2022.The cerenovous neurothrombectomy device was attempted to be used as the first line of treatment in this subject for intracranial clot removal.The first, second, and third passes were made with the embotrap device in the right m1 segment of the middle cerebral artery.The pre-pass mtici score was 0 for the first two passes and 1 for the third pass.The first pass resulted in an mtici score of 0, with clot retrieval in the stent retriever and the second and third passes resulted in an mtici score of 1, with no clot retrieval.The fourth and fifth passes were made using a 4mm x 20mm trevo stent retriever (stryker) in the right m1 segment of the middle cerebral artery.The previous device was changed due to a persistent clot.During all passes of the procedure, a guidewire was used, but the band was not specified.In addition, a 0.021 trevo microcatheter (stryker), an 8 flowgate 2 balloon guide (stryker), and a sofia intermediate catheter were used.No further passes were made.The 24-hour post-procedure nihss score was 13.The patient was discharged to a nursing home on (b)(6) 2022 with an nihss score of 13 and an mrs score of 4.On (b)(6) 2022 the patient experienced brain bleeding.The principal investigator assessed this event as severe in severity, serious, possibly related to the embotrap device, and probably related to the procedure.The patient expired on the same day.

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient race, and ethnicity was not reported.Patient identifier (b)(6).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).Section b5: modified information was received from the study database on 24-feb-2023.Summary of additional information provided: in the opinion of the principal investigator and in accordance with the list of expected events in the protocol and instructions for use, the brain bleeding changed from the adverse event being expected/anticipated to unexpected/unanticipated.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).Complaint conclusion: as reported via the excellent study, an 82-year-old female (subject (b)(6)) with a history of diabetes, hyperlipidemia, and hypertension presented with a stroke on an unknown date.The first symptoms were observed on (b)(6) 2022 and the patient presented to the hospital on the same day.Intravenous tissue plasminogen activator (tpa) was not administered at the time of stroke presentation.The suspected origin of the embolism was a pancreatic carcinoma.The patient¿s baseline nihss score was 12, and the mrs score was 0.The patient underwent an endovascular mechanical thrombectomy using a 5mm x 22mm embotrap iii (et307537/22d064av) device on (b)(6) 2022.The cerenovous neurothrombectomy device was attempted to be used as the first line of treatment in this subject for intracranial clot removal.The first, second, and third passes were made with the embotrap device in the right m1 segment of the middle cerebral artery.The pre-pass mtici score was 0 for the first two passes and 1 for the third pass.The first pass resulted in an mtici score of 0, with clot retrieval in the stent retriever and the second and third passes resulted in an mtici score of 1, with no clot retrieval.The fourth and fifth passes were made using a 4mm x 20mm trevo stent retriever (stryker) in the right m1 segment of the middle cerebral artery.The previous device was changed due to a persistent clot.During all passes of the procedure, a guidewire was used, but the band was not specified.In addition, a 0.021 trevo microcatheter (stryker), an 8 flowgate 2 balloon guide (stryker), and a sofia intermediate catheter were used.No further passes were made.The 24-hour post-procedure nihss score was 13.The patient was discharged to a nursing home on (b)(6) 2022 with an nihss score of 13 and an mrs score of 4.On (b)(6) 2022 the patient experienced brain bleeding.The principal investigator assessed this event as severe in severity, serious, possibly related to the embotrap device, and probably related to the procedure.The patient expired on the same day.The device was discarded; therefore, no further investigation can be performed.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.All accepted and rejected units were accounted for during the dhr review.Cerebral hemorrhage and death are potential complications associated with the embotrap iii device and are listed in the instructions for use (ifu) as such.The device was unable to remove the clot, but it was not related to a device malfunction.The reported outcome is not related to the device or the procedure; it is a natural progression of the underlying disease process.However, the principal investigator assessed, this event, which resulted in the patient¿s death, as possibly related to the embotrap device, and probably related to the primary surgical procedure.Therefore, this event does meet mdr reporting criteria as a ¿death¿ 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.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: modified information was received from the study database on 08-mar-2023.Summary of additional information provided: in the opinion of the principal investigator and in accordance with the list of expected events in the protocol and instructions for use, the brain bleeding changed from the adverse event being unexpected/unanticipated to expected/anticipated.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).Section b5: additional information was received on 07-feb-2023.Summary of additional information provided: in the opinion of the principal investigator and in accordance with the list of expected events in the protocol and instructions for use, the brain bleeding adverse event is expected/anticipated.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include modified additional event information received on 30-mar-2023.[additional information]: on 30-mar-2023, modified information was received from the study site.The relationship between the adverse event ¿brain bleeding¿ and the study device was updated from ¿possible¿ to ¿not related.¿ cerebral hemorrhage and death are potential complications associated with the embotrap iii device and are listed in the instructions for use (ifu) as such.The device was unable to remove the clot, but it was not related to a device malfunction.The reported outcome is not related to the device or the procedure; it is a natural progression of the underlying disease process.Per modified information received on 30-mar-2023, the relationship between the adverse event ¿brain bleeding¿ and the study device was updated from "possible" to "not related¿.However, the relationship between the adverse event, which was fatal, and the use of the device cannot be excluded and therefore could be a remote factor.As a result, this event will be conservatively reported to the usfda reportable under title 21 cfr 803 with a classification of ¿death¿.The file will be re-reviewed if additional information is received at a later date.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 5 MM X 22 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16036009
• MDR Text Key: 306018165
• Report Number: 3011370111-2022-00125
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ET307522
• Device Lot Number: 22D064AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.021 TREVO MICROCATHETER (STRYKER); 4MM X 20MM TREVO STENT RETRIEVER (STRYKER); 8 FLOWGATE 2 BALLOON GUIDE (STRYKER); A SOFIA INTERMEDIATE CATHETER; GUIDEWIRE
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 55 KG