MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number ET009533

Device Problems Entrapment of Device (1212); Patient-Device Incompatibility (2682)

Patient Problem Insufficient Information (4580)

Event Date 08/13/2022

Event Type  Death  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.The expiration date of the device is not known as the device lot number is not available / not reported.Initial reporter information such as facility name, initial reporter name, address, phone and email address are not available.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the reported event was identified via the maude database involving a 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown).A 92-year-old patient underwent a thrombectomy procedure where the 5mm x 33mm embotrap ii revascularization device was used.It was reported that ¿on the 4th pass, the embotrap ii device was approximately 2/3 into the walrus 087 balloon guide catheter (q¿apel) (bg8087-095 / fg22011j-02) when it became entangled.¿ the physician removed both the walrus balloon guide catheter and the embotrap ii device from the patient.It was reported that the 92-year-old patient expired post-procedure.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 evaluation and analysis cannot be conducted as the product was not available to be returned.Determination of causes and possible contributing factors could not be made.As such, the investigation will be closed.Device entanglement with another device is a known potential complications associated with the use of embotrap ii revascularization device in endovascular mechanical thrombectomy procedures.The instructions for use (ifu) warns the user to not use any embotrap ii revascularization device more than 3 times and to not perform more than 3 retrieval attempts in any one vessel.At this time, it is not clear what were the chains of events after the device became entangled, but since it culminated in death of the patient and the relationship of the device to the fatal outcome cannot be excluded, the event meets mdr reporting criteria with the classification of ¿death.¿ 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.

Event Description

The reported event was identified via the maude database involving a 5mm x 33mm embotrap ii revascularization device (et009533 / lot# unknown).A 92-year-old patient underwent a thrombectomy procedure where the 5mm x 33mm embotrap ii revascularization device was used.It was reported that ¿on the 4th pass, the embotrap ii device was approximately 2/3 into the walrus 087 balloon guide catheter (q¿apel) (bg8087-095 / fg22011j-02) when it became entangled.¿ the physician removed both the walrus balloon guide catheter and the embotrap ii device from the patient.It was reported that the 92-year-old patient expired post-procedure.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• 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: 15821187
• MDR Text Key: 303889442
• Report Number: 3011370111-2022-00111
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/17/2022

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 Model Number: ET009533
• Device Catalogue Number: ET009533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: WALRUS 087 BALLOON GUIDE CATHETER (Q¿APEL).
• Patient Outcome(s): Death
• Patient Age: 92 YR