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

Catalog Number ET309645

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Ischemia Stroke (4418)

Event Date 08/03/2023

Event Type  Death  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth was not provided.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device was not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (23c155av) 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.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 is a known potential complication associated with the use of both the embotrap iii device and the emboguard balloon guide catheter and is listed as such in the instructions for use (ifu) for both devices.The principal investigator (pi) assessed the cerebral infarction event of as unrelated to the embotrap iii study device, unrelated to the large bore catheter, and unrelated to the primary surgical procedure.However, because the embotrap iii device was ineffective at treating the occlusion, (which is defined as the inability to remove the target thrombus from the treated vessel after 3 passes, resulting in a mtici score of =2a), and the event having occurred a few days after the procedure without it being known if there were any intraoperative device deficiencies, the correlating relationship between the cerebral infarction to the devices cannot be ruled out.Based on this information, this event meets us fda reporting criteria under 21 cfr 803 under the classification of ¿death.¿ the file will be re-reviewed if additional information is received at a later date.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2023-00112 and 3011370111-2023-00120.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 event was reported via the excellent study, the 89-year-old female patient with no medical history presented with a witnessed stroke on (b)(6) 2023 at 08:41 am and presented to the treating hospital on the same day at 09:41 am, where computed tomography (ct) imaging confirmed an ischemic stroke.Intravenous tissue plasminogen activator (tpa) was not administered.The suspected origin of the embolism was large artery disease (intracranial atherosclerosis).The patient¿s baseline a nih stroke scale (nihss) score was 22 and a modified rankin assessment was not performed.The patient underwent an endovascular mechanical thrombectomy on (b)(6) 2023 using a 6.5mm x 45mm embotrap iii revascularization device (et309645 / 23c155av).The pre-pass modified treatment in cerebral infarction (mtici) score was 0.The first pass targeted an occlusion in the left internal carotid artery (ica) resulted in an mtici score of 2a with no clot retrieval.The second and third pass were made targeting the same left ica resulted in an mtici score of 2a with the clot retrieved only on the third pass.Concomitant devices used during the procedure were a guidewire (unspecified brand), an emboguard balloon catheter (catalog / lot# unknown), a phenom¿ 021 microcatheter (medtronic), and an esperance¿ aspiration catheter (wallaby medical).It is unknown if there were any intraoperative study device deficiencies.The patient¿s 24-hour post-procedure assessment did occur on (b)(6) 2023, however, the nihss assessment was not performed.The patient¿s discharge information was not entered into the case report form (crf), but it was documented the patient was admitted to ¿medical/surgical floor or routine care¿ on (b)(6) 2023.No further assessment were performed.On (b)(6) 2023, the patient suffered a cerebral infarction.The principal investigator (pi) assessed this event as serious, severe adverse event that was unrelated to the embotrap iii study device, unrelated to the primary procedure.The event was not medically treated.The outcome was fatal and the patient expired on the same day.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional and modified information received on 30-oct-2023 that changed the reportability of the event as related to the product reported in this medwatch report.[additional & modified information]: on 30-oct-2023, additional information was received from the excellent study clinical team.Per the information the catalog of the emboguard balloon catheter used was bg8795u, the lot number is not known.Modified information was also received: per the modified information, the adverse event term ¿cerebral infarction¿ was updated to ¿progression of stroke.¿ the following fields related to the adverse event were also updated as follows: if event is both serious and device or procedure related, in the opinion of the investigator and in accordance with the list of expected events in the protocol and instructions for use, is the adverse event: updated from ¿blank¿ to "expected/anticipated." if event is both serious and device or procedure related, in the opinion of the investigator and in accordance with the list of expected events in the protocol and instructions for use, is the adverse event: "expected/anticipated" updated to "n/a (does not meet above criteria)." per the additional information received in 30-oct-2023, the clarification of the cerebral infarction being a progression of the index stroke was discussed with the medical safety officer, mso, on (b)(6) 2023.Per the mso, since the event was not a new cerebral event, but was the progression of the index stroke, the event and the outcome of death would not be related to the study device.This is further confirmed by the patient¿s baseline nihss score of 22 that signifies a poor prognosis which progressed despite reperfusion achieved during the procedure.Per the additional/modified information received on 30-oct-2023, the adverse event term ¿cerebral infarction¿ was updated to ¿progression of stroke¿, which confirms the patient did not have a second stroke subsequent to the procedure.Progression of an index stroke is defined as a complex series of biochemical events (often termed the ¿ischemic cascade¿) that occur over a period of hours or even days after the initial stroke.The degree to which the initial ischemic injury, the secondary cascade of inflammatory responses, and their associated complications play a role in the overall development of brain infarction, and the nihss score is strongly correlating to the patient¿s outcome after a stroke; a score greater than 16 is related to a strong probability of death.Review of the information suggests that patient factors, including the patient¿s baseline stroke (baseline nihss score of 22) and comorbidities, may have contributed to the death, with no indication of device malfunction.It was also confirmed on the clinical database, the crf, that there were no device deficiencies during the procedure.Based on this information and the assessment of the pi, the event of ¿progression of stroke¿ and the outcome of death no longer meets us fda reporting criteria under 21 cfr 803.The file will be re-reviewed if additional information is received at a later date.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2023-00112 and 3011370111-2023-00120.Based on the information provided, the event no longer meets medical device reporting criteria.No further report will be forthcoming.

• 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 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 ; 303552-689
• MDR Report Key: 17634529
• MDR Text Key: 322093137
• Report Number: 3011370111-2023-00112
• 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: K211338
• 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
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ET309645
• Device Lot Number: 23C155AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2023
• 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: EMBOGUARD 87, 95 CM; ESPERANCE¿ ASPIRATION CATHETER (WALLABY MEDICAL); PHENOM¿ 021 MICROCATHETER (MEDTRONIC); UNKNOWN EMBOGUARD BALLOON
• Patient Outcome(s): Death
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian