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 04/30/2019

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: 3011370111-2021-00100.3011370111-2021-00101.3011370111-2021-00102.3011370111-2021-00103.And 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 6 patients underwent mechanical thrombectomy and suffered in-hospital mortality.Model and catalog number are not available, but the suspected device is the embotrap other cnv devices that were also used in this study: none.Non-cnv devices that were also used in this study: flowgate (stryker), solitaire (medtronic), trevo (stryker), ace (penumbra), axscat5 (stryker), axscat6 (stryker), sofia 5f (microvention), sofia 6f(microvention), (penumbra aspiration system).Publication details: title: comparison of first-pass efficacy among four mechanical thrombectomy.Techniques: a single-center experience.Objective: d: first-pass efficacy (fpe) is an established marker of technical and clinical efficacy among mechanical thrombectomy (mt) techniques.It is unclear what the optimal approach is in achieving fpe.We present a single-center experience comparing rates of fpe among 2 mt techniques and evaluate the potential predictors of fpe among other outcomes.Methods: a single-center retrospective analysis was carried out of patients with consecutive large-vessel occlusion strokes (lvos) of anterior circulation from (b)(6) 2015 to (b)(6) 2019 who underwent mt and for whom data were available on the status of fpe.Four mt techniques were identified: adapt (a direct first-pass aspiration), sradapt (stent retriever with aspiration), srbg (stent retriever with balloon guide catheter), and strap (stent retriever-aspiration and proximal flow arrest).The primary outcome was fpe and secondary outcomes included the rate of successful reperfusion.

• 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 ; 949789-868
• MDR Report Key: 12378503
• MDR Text Key: 268513027
• Report Number: 3011370111-2021-00104
• Device Sequence Number: 1
• Product Code: NRY
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 08/02/2021
• 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: ACE (PENUMBRA); AXSCAT5 (STRYKER); AXSCAT6 (STRYKER); FLOWGATE (STRYKER); PENUMBRA ASPIRATION SYSTEM; SOFIA 5F (MICROVENTION); SOFIA 6F(MICROVENTION); SOLITAIRE (MEDTRONIC); TREVO (STRYKER)
• Patient Outcome(s): Death
• Patient Age: 67 YR