MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNK COIL-HYDRAULIC; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number UNK COIL-HYDRAULIC

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2008

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (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.Cerenovus manufacturer's report numbers: 3008114965-2021-00305, 3008114965-2021-00306, and 3008114965-2021-00308 are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 4 patients underwent endovascular embolization and suffered am unstable basket.Intervention was bailout stent deployment.Model and catalog number are not available, but the suspected device is trufill detachable coil system.Other cnv devices that were also used in this study: agility guidewire non-cnv devices that were also used in this study: guglielmi detachable coils, microplex, axium, (transend floppy 300 cm), neuroform stent.Title: bailout stent deployment during coil embolization of intracranial aneurysms.Objective: self-expandable stents are an effective tool for coil embolization of wide-neck intracranial aneurysms.The purpose of this study was to assess the feasibility and results of bailout stent positioning during rescue situations after deployment of 1 coil.Methods: among 318 aneurysms treated by coil embolization in 267 patients, 16 patients who were treated by bailout stent deployment were retrospectively reviewed.Bailout procedures were performed to relieve potential parent artery compromise caused by the protruded coil loops or to prevent migration of the unstable coil basket.The size/location of the aneurysm, technical feasibility, successful stabilization rate, and procedure-related complications were evaluated.

• Brand Name: UNK COIL-HYDRAULIC
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine 92618 ; 949789-868
• MDR Report Key: 12168574
• MDR Text Key: 265012249
• Report Number: 3008114965-2021-00307
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K123560
• 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: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK COIL-HYDRAULIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2021
• 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 Age: 60 YR