MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X21 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number	ET009521
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Expiration date - not available at time of report.Device manufacture date - not available at time of report.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 company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported via the excellent study, a (b)(6)-year-old female (subject (b)(4)) with a history of ischemic stroke (1995), hyperlipidemia, hypertension, previous coronary artery bypass grafting (cabg), smoking (previous), arthritis, and class 1 obesity (bmi 32 kg/m2) experienced an in-hospital witnessed stroke on (b)(6) 2020 with mtici score of 0, nihss score of 26, and mrs score of 0 and experienced severe re-occlusion of the left middle cerebral artery (mca) on the same day.The event resolved on the same day with unspecified medication and cerebral angiogram with embolectomy.Per the principal investigator (pi), the event was possibly related to the study device and procedure.The patient underwent a mechanical thrombectomy using a 5x21 embotrap ii (et009521/19k109av) device on (b)(6) 2020.The suspected origin of embolism was cardioembolic.Intravenous tissue plasminogen activator (tpa) was not administered.The first pass made with the embotrap and mechanical pump aspiration at left m1 segment of the mca (2 min incubation) resulted in mtici score of 3 with clot retrieval via the pump.No further passes were made.The embotrap pass was made with an 0.090¿ cerebase da catheter with an 0.071¿ large bore catheter (lbc) via an 0.027¿ excelsior microcatheter.There were no reported intraoperative complications or study device deficiencies.The patient experienced re-occlusion of the left mca on the same day as the procedure which necessitated embolectomy.24-hour post-procedure nihss score was 4.The patient was discharged to a rehabilitation center on (b)(6) 2020.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr is to include the additional event information received on (b)(6)2020.Modified information received from the clinical database was reviewed.¿relationship to study device¿ value ¿possible¿ was changed to ¿not related¿.E-mail message received from the clinical study contact on (b)(6)2020 noted that he received word from the site that the principle investigator (pi) re-assessed the event as not related to the study device; however, the relatedness to procedure should remain as is.Since the pi felt the re-occlusion was not related to the study device, the event meet no longer meets mdr reporting criteria.

• Brand Name: EMBOTRAP II 5X21 REVASC. DEV.
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt; business park; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 10265044
• Report Number: 3011370111-2020-00052
• Device Sequence Number: 19584333
• Product Code: NRY
• UDI-Device Identifier: 10886704081319
• UDI-Public: 10886704081319
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2020

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
• Operator of Device: Health Professional
• Device Model Number: ET009521
• Device Catalogue Number: ET009521
• Device Lot Number: 19K109AV
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 08/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.027¿ EXCELSIOR MICROCATHETER.; 0.071¿ LARGE BORE CATHETER (LBC).; 0.090¿ CEREBASE DA CATHETER.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 79