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 Problems Infarction, Cerebral (1771); No Code Available (3191)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 3011370111-2020-00002, 3011370111-2020-00004, and 3011370111-2020-00005 are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿intracranial stenting after failure of thrombectomy with the embotrap® device¿ (pmid: 29845367).12 patients with acute stroke caused by large vessel occlusions and treated with the embotrap® device experienced re-occlusion and cerebral infarction.The patients were treated with intracranial stenting.Background: primary permanent intracranial stenting was initially used in the era before thrombectomy and might still be a useful rescue treatment in acute stroke patients suffering from ongoing large vessel occlusion refractory to thrombectomy.Methods: the prospectively collected registry of patients with acute stroke caused by large vessel occlusions and treated with the embotrap® device in (b)(6) hospital from october 2013 through march 2017 were retrospectively reviewed.Clinical outcome of non-recanalized patients with thrombolysis in cerebral infarction (tici) score of 0¿1 after failed thrombectomy were compared with those who were treated with permanent intracranial stenting as rescue therapy.Favorable outcome was defined as a modified rankin scale 0¿2.The embotrap® device was used in 201 patients.No device-specific information (including catalog and lot number) were provided in the article.

• Brand Name: UNK_THROMBECTOMY NEURAVI
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; see h10; 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: 9570926
• MDR Text Key: 189451116
• Report Number: 3011370111-2020-00003
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: UNK
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR