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 Hemorrhage, Cerebral (1889); Vasoconstriction (2126)

Event Date 05/05/2017

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.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.  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, ¿implementation of penumbra-assisted half-stent thrombectomy for patients with acute m2 occlusion: results of initial experiences.¿ a patient with acute ischemic stroke (m2 artery occlusion) who underwent mechanical thrombectomy with revive se stent-retriever experienced vasospasm and asymptomatic intracranial hemorrhage.Object: demonstration of initial experience penumbra-assisted half-stent thrombectomy for patients with acute m2 occlusion.Method: from november 2016 to may 2017, 12 cases for acute cerebral major artery occlusion were reviewed.These included 6 cases of acute m2 occlusion that received a penumbra-assisted half-stent thrombectomy.

• 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: 10133742
• MDR Text Key: 195906114
• Report Number: 3008114965-2020-00239
• 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: 05/19/2020

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: 05/19/2020
• Initial Date FDA Received: 06/09/2020
• 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: 75 YR