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 Date 03/31/2020

Event Type  Death  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Cerenovus manufacturer's report numbers: 3011370111-2021-00069, 3011370111-2021-00070, 3011370111-2021-00071, 3011370111-2021-00073, 3011370111-2021-00074, 3011370111-2021-00075.Are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 3 patients underwent mechanical thrombectomy due to large vessel occlusion and suffered death due to therapy limitation.Intervention was not reported.Model and catalog number are not available, but the suspected device is embotrap revascularization device.Other biosense webster devices that were also used in this study: none non-biosense webster devices that were also used in this study: solitaire stent-retriever (medtronic), trevo xp provue retriever (stryker), a sofia catheter (microvention).Publication details: title: mortality after mechanical thrombectomy in anterior circulation stroke may be higher at nighttime and on weekends.Objective: the objective of this study was to compare clinical outcome and procedural differences of mechanical thrombectomy (mt) during on-call with regular operating hours.We particularly focused on dosimetric data which may serve as potential surrogates for patient outcome.Methods: a total of 246 consecutive patients who underwent mt in acute anterior circulation stroke between november 2017 and march 2020 were retrospectively included.Patients treated (1) during standard operational hours (n = 102), (2) daytime oncall duty (n = 38) and (3) nighttime on-call duty (n = 106) were compared with respect to their pre-interventional status, procedural specifics, including dosimetrics(dose area product (dap), fluoroscopy time and procedural time), and outcome.

• Brand Name: UNK_THROMBECTOMY NEURAVI
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; 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: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12334647
• MDR Text Key: 267024192
• Report Number: 3011370111-2021-00072
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2021

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: No Information
• Device Catalogue Number: UNK_THROMBECTOMY NEURAVI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/17/2021
• 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: SOFIA CATHETER (MICROVENTION); SOLITAIRE STENT-RETRIEVER (MEDTRONIC); TREVO XP PROVUE RETRIEVER (STRYKER)
• Patient Outcome(s): Death
• Patient Age: 75 YR