MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL COIL-THERMO MECHANICAL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number UNK-CNV DCS COILS

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

Patient Problem Stroke/CVA (1770)

Event Date 01/31/2004

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.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 lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent coil embolization of an intracranial aneurysm and suffered a stroke at post op day 2 related to procedure.Patient treated with a combination of matrix and bpcs (which includes dsc).Intervention was not reported.There are 0 device malfunctions reported in this publication.Model and catalog number are not available, but the suspected device is: dcs.Other cnv devices that were also used in this study: prowler 14-microcatheter, agility 10, agility 14.Non-cnv devices that were also used in this study: artis, (siemens), synchro 10, synchro 14, matrix coils, guglielmi detachable coils.Title: polyglycolide/polylactide-coated platinum coils for patients with ruptured and unruptured cerebral aneurysms: a single-center experience.Objective: recanalization of cerebral aneurysm is a limitation of bare platinum coils (bpcs).In a swine aneurysm model, polyglycolide/polylactide (a polymer)-coated platinum coils (matrix) accelerated clot fibrosis and reduced recanalization rate and aneurysmal volume.We aimed to evaluate the safety of matrix coils in patients with intracranial aneurysm.Methods: this is a single-center, prospective study of patients with intracranial aneurysms treated with matrix alone or in combination with bpcs.Follow-up evaluation included a 1-month clinical evaluation and a 6- and 12-month clinical and angiographic examination.Primary adverse events included death, stroke, and permanent neurological deficits.

• Brand Name: COIL-THERMO MECHANICAL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; 821 fox lane; san jose CA ; CA
• Manufacturer (Section G): MICRUS ENDOVASCULAR; 821 fox lane; san jose CA
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 11729704
• MDR Text Key: 262902079
• Report Number: 2954740-2021-00003
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CNV DCS COILS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR