MAUDE Adverse Event Report: NEURAVI LTD. UNK_THROMBECTOMY NEURAVI; CATHETER, THROMBUS RETRIEVER

Catalog Number UNK_THROMBECTOMY NEURAVI

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Date of event: the date of the event/study is not known.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Information such as initial reporter facility name, address, city, state, name, phone, and email address are not available / reported.The device manufacture date is not known as the product lot number of the device is not available / not reported.[conclusion]: it was reported through the database related research activities (drra) report source on behalf of the md-epidemiology, the following complications were reported in the drra potential complaint form and final study report (study number (b)(6)), aligned to a cerenovus product (embotrap (first or second generation) stent-retriever device) during the analysis years of july 2018 ¿ december 2020.It was reported that eleven (11) patients with a primary diagnosis of acute ischemic stroke underwent a thrombectomy procedure with the embotrap stent-retriever (unknown product code/unknown lot #) device and post discharge 30-day were admitted for all causes.Based on complaint information, the device was 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.In addition, there was no report of malfunction associated with the device.As such, the investigation will be closed.Since the events led to readmission and hospitalization, these events are considered mdr reportable.With extremely limited information available, the relationship between device and readmission and hospitalization cannot be determined.There was no information on patient medical history, and no information on the device and its performance during use in the study procedure and no information related to concomitant devices used during the procedure.The device catalog and lot numbers are not known; therefore, the determination of possible device-related causes cannot be determined through device analysis or through device history record review.The exact cause of the event could not be conclusively determined.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 is one of five products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2021-00087, 3011370111-2021-00089, 3011370111-2021-00090, and 3011370111-2021-00091.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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

It was reported through the database related research activities (drra) report source on behalf of the md-epidemiology, the following complications were reported in the drra potential complaint form and final study report (study number (b)(6)), aligned to a cerenovus product (embotrap (first or second generation) stent-retriever device) during the analysis years of july 2018 ¿ december 2020.It was reported that eleven (11) patients with a primary diagnosis of acute ischemic stroke underwent a thrombectomy procedure with the embotrap stent-retriever (unknown product code/unknown lot #) device and post discharge 30-day were admitted for all causes.

• Brand Name: UNK_THROMBECTOMY NEURAVI
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 12374567
• MDR Text Key: 280580138
• Report Number: 3011370111-2021-00088
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_THROMBECTOMY NEURAVI
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization