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 Death (1802); Edema (1820)

Event Date 11/30/2018

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 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 cerenovus manufacturer's report numbers: 3008114965-2020-00100, 3008114965-2020-00101 are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿comparison of aspiration versus stent retriever thrombectomy as the preferred strategy for patients with acute terminal internal carotid artery occlusion: a propensity score matching analysis¿ 4 patients with acute terminal internal carotid artery occlusion who underwent stent retriever thrombectomy ( from the stent retriever thrombectomy group) died due to malignant cerebral edema.The purpose of this study was to evaluate the comparative safety and efficacy of preferred aspiration thrombectomy and stent retriever thrombectomy for revascularization in patients with isolated terminal ica occlusion.Materials and methods: retrospective analysis of patients with terminal ica occlusion treated with aspiration thrombectomy or stent retriever thrombectomy was performed, from september 2013 to november 2018.Y events related to revive devices (per assumption) were captured in this complaint.

• 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: 9936241
• MDR Text Key: 186832503
• Report Number: 3008114965-2020-00102
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/18/2020

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: 03/18/2020
• Initial Date FDA Received: 04/08/2020
• 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: 69 YR