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 Problem Hemorrhage, Cerebral (1889)

Event Date 12/31/2016

Event Type  Injury  

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 the no lot number was provided by the customer.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿endovascular therapies for acute ischemic stroke in children.¿ 1 patient with pediatric acute ischemic stroke from ia mechanical thrombectomy group who underwent mechanical thrombectomy experienced cerebral hemorrhage.Objectives: retrospective case review of endovascular management of pediatric ais, with a focus on efficacy and safety.Methods: 68 cases of pediatric ais (acute ischemic stroke) treated with ia (intra-arterial) fibrinolysis and ia (intra-arterial) mechanical thrombectomy from (b)(6) 1990 through (b)(6) 2016 were reviewed.

• 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: 10090076
• MDR Text Key: 194961492
• Report Number: 3008114965-2020-00193
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 05/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/06/2020
• Initial Date FDA Received: 05/26/2020
• 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): Other
• Patient Age: 10 YR