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

Catalog Number ET309645

Device Problem Difficult to Remove (1528)

Patient Problem Vasoconstriction (2126)

Event Date 08/13/2023

Event Type  Injury  

Event Description

It was reported that a spasm occurred during a mechanical thrombectomy procedure targeting an occlusion in the internal carotid artery (ica).The spasm reportedly caused resistance when the 6.5mm x 45mm embotrap iii revascularization device (catalog #et309645 / lot # unknown) was retrieved.The embotrap iii device was withdrawn into the concomitant microcatheter, a marksman¿ microcatheter (medtronic).It was reported that the physician considered one more pass, but the procedure was determined to be completed as recanalization had been achieved.A continuous flush had been maintained through the device during the procedure.The patient¿s progress was reported to be ¿fine.¿.

Manufacturer Narrative

Manufacturer's reference number: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d4: the expiration date of the device is not known as the device lot number is not available / not reported.Section e1 initial reporter phone: (b)(6).Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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.Vasospasm is a known potential complication associated with the use of the embotrap iii revascularization device and is listed in the instructions for use (ifu) as such.The event of ¿arterial spasm¿ resulted in withdrawal difficulty of the device from the vessel.The movement of the device against resistance has the potential of dislodging a clot, perforating a vessel wall, or damaging the device.Since the relationship of the embotrap iii revascularization device to the reported event cannot be excluded, the event will be conservatively reported to the us fda under criteria 21 cfr 803 with a classification of ¿serious injury." 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 issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review was not performed.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.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.

Manufacturer Narrative

Manufacturer¿s reference number: (b)(4).The purpose of this mdr submission is to include the additional event information received on 20-sep-2023 and 21-sep-2023.The lot number of the suspect medical device is 22l143av.A review of the dhr records confirms that there were no issues with the assembly of the lots (sub-assembly and top assembly), and were assembled as per dmr requirements.All accepted and rejected units were accounted for during the dhr review.The embotrap iii device made a total of one (1) pass.When the reported spasm was observed, it was on the one and only pass.The spasm lasted about 10 minutes.No medication was provided.Per the physician¿s opinion on the possible cause of the reported spasm, ¿the patient was female and had severe vascular tortuosity, so spasm was more likely to occur.¿ the patient¿s vessel was reported to be relatively severe tortuosity.The reported pre- and post-procedure tici scores was 2b.Per the additional information, the made one pass and considered one more pass, but recanalization was achieved, the second pass was not made, and the procedure was terminated ¿due to concerns about the risk.¿ the information also indicated that there was ¿small resistance felt during withdrawal.¿.

• 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 ; 3035526892
• MDR Report Key: 17705612
• MDR Text Key: 322923798
• Report Number: 3011370111-2023-00131
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ET309645
• Device Lot Number: 22L143AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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: MARKSMAN¿ MICROCATHETER (MEDTRONIC).
• Patient Outcome(s): Life Threatening
• Patient Sex: Female