MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL REVIVE SE 4.5MM OUS; EMBOLECTOMY CATHETER

Catalog Number FRS21452299

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

Patient Problems Stroke/CVA (1770); Death (1802)

Event Date 01/31/2013

Event Type  Death  

Manufacturer Narrative

Product complaint # (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: 3008114965-2020-00200, 3008114965-2020-00201, 3008114965-2020-00202, 3008114965-2020-00203, and 3008114965-2020-00206 are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿mechanical thrombectomy for ischaemic stroke: the first uk case series.¿ 1 patient with acute ischemic stroke who underwent endovascular treatment with thrombectomy died due to later complications of the persistent severe stroke.Purpose: endovascular treatments have the potential to accelerate reperfusion in acute ischaemic stroke with large vessel occlusion.Results of the first 106 endovascular treatments (evt) in the uk were presented in the article.Methods: from december 2009 to january 2013 106 patients (mean age 64 years, median baseline nihss 18) were treated with evt (thrombectomy ± iat 83%, iat (intra-arterial thrombolysis) alone 13%, neither 4%).

• Brand Name: REVIVE SE 4.5MM OUS
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10092577
• MDR Text Key: 192200297
• Report Number: 3008114965-2020-00205
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• 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: 05/05/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: FRS21452299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/27/2020
• 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): Death
• Patient Age: 64 YR