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

Catalog Number ET307645

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 01/13/2023

Event Type  Death  

Event Description

The healthcare professional reported that in a thrombectomy procedure, a.5mm x 45mm embotrap iii revascularization device (et307645 / 22e175av) was used.During thrombus removal, a vessel was perforated and death of the patient occurred.It was stated that, ¿such a situation can happen and most likely it was not the fault of the equipment, but it was used.¿ no further information was provided at the time of the complaint initiation.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Date of death: the date of death is not known.Date of event: the date of the event is not known.Initial reporter: the name, phone and email address of the initial reporter are not available / reported.Device evaluated by mfr: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of the manufacturing documentation associated with this lot (22e175av) 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.Vessel perforation and death are potential complications associated with the embotrap device and are listed in the instructions for use (ifu) as such.Although no malfunction has been reported, and it was stated that ¿such a situation can happen and most likely it was not the fault of the equipment¿, the relationship of the embotrap device to the reported vessel perforation and patient death cannot be excluded.Therefore, this event is 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.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.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 21-apr-2023.[additional information]: on 21-apr-2023, additional information was received.The information indicated that the thrombectomy procedure was on (b)(6) 2023.The patient expired on (b)(6) 2023, two (2) days after the thrombectomy procedure.The official cause of death was ¿brainstem death.¿ the information indicated that the location of the target thrombus was a carotid t occlusion.The clot was a red clot, 50-70 hounsfield units (hu) and approximately 2.5cm in length.The patient¿s modified rankin scale (mrs) score was 0, nih stroke scale (nihss) score was 18, and the alberta stroke program early ct score (aspects) was 3.The physician thought that it may have been the withdrawal of the stent retriever and/or the increased pressure in the internal carotid artery (ica) that may have caused / contributed to the vessel perforation that may have caused / contributed to the death of the patient.Two (2) passes were made with the embotrap iii device plus distal aspiration with the distal access guide catheter (dac).The information indicated that a continuous flush was not maintained through the microcatheter during the procedure.There was a ¿slightly increased resistance during withdrawal¿ of the embotrap iii device.The microcatheter used was a phenom¿ 17 microcatheter (medtronic).The guide catheter used was an 8 fr, 90 cm cerebase da guide sheath (gs9090sd).The complaint product is also no longer available for return.It has been discarded.Based on complaint information, the device is not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (22e175av) 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.Vessel perforation and death are potential complications associated with the embotrap device and are listed in the instructions for use (ifu) as such.Per the additional information received on 21-apr-2023, there was a ¿slightly increased resistance during withdrawal¿ of the embotrap iii device.Withdrawal difficulty from a vessel could result in vessel trauma, vessel spasm, and damage to the basket with the potential for the release of emboli and subsequent ischemia or infarction, and/or the need for additional intervention.Therefore, this event is usfda reportable under 21 cfr 803 with a classification of ¿death.¿ the file will be re-reviewed if additional information is received at a later date.With the information available and without the complaint product available to be returned for analysis, the reported product issue could not be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.2, b.3, b.4, 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 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: 16660608
• MDR Text Key: 312489369
• Report Number: 3011370111-2023-00044
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ET307645
• Device Lot Number: 22E175AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 03/31/2023
• Supplement Dates Manufacturer Received: 04/21/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2022
• 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: GS 90, 90 CM, STRAIGHT, DISTAL; PHENOM¿ 17 MICROCATHETER (MEDTRONIC)
• Patient Outcome(s): Death