MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL THROMBECTOMY; EMBOLECTOMY CATHETER

Catalog Number UNKREVIVESE

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation summary > since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: kinjo n, yoshimura s, uchida k, sakai n, yamagami h, morimoto t; rescue-japan registry 2 investigators.Incidence and prognostic impact of intracranial hemorrhage after endovascular treatment for acute large vessel occlusion.Cerebrovasc dis.2020;49(5):540-549.Doi: 10.1159/000510970.Epub 2020 oct 20.Pmid: 33080610.Objective: investigate the impact of ich after evt on functional outcome at 90 days in patients with acute lvo.Methods/study data: analyzed 1,281 patients who received evt and compared the functional outcomes between those with and without ich (ich and no-ich groups, respectively) within 24 h after evt.Explored the factors associated with ich and prognostic impact of symptomatic ich (sich) among patients with ich.Estimated the adjusted odds ratios (ors) for good functional outcome as modified rankin scale scores 0-2 and mortality.Explored the prognostic impact of symptomatic ich (sich) among patients with ich.Article does not report deaths related to product or procedure and only speaks to mortality at 90 days without cause.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: revive stent retriever other cerenovus devices that were also used in this study: n/a non-cerenovus devices that were also used in this study: solitairetm 2 revascularization device (covidien, irvine, ca, usa), trevo provue retriever/trevo® xp provue retriever (stryker, fremont, ca, usa).The aspiration catheter used was the penumbra system® (penumbra, alameda, ca, usa).Exact quantities cannot be determined accurately as the article does not provide specific details regarding quantities of ich related to specific manufacturers.Adverse event(s) and provided interventions: article reports occurrence of intracranial hemorrhage in 26% of patient data occurring within 24 hours of procedure (interventions not specified).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).(b)(4) under mrn 2954740-2021-00005 is being retracted.(b)(4) under mrn 2954740-2021-00005 is being retracted.

• Brand Name: THROMBECTOMY
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; 821 fox lane; san jose CA ; CA
• MDR Report Key: 12396106
• MDR Text Key: 269325518
• Report Number: 2954740-2021-00005
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

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: UNKREVIVESE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/06/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 08/06/2021
• Supplement Dates FDA Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other