MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-ECHELON

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

Patient Problem Sepsis (2067)

Event Date 08/01/2015

Event Type  Death  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The purpose of the article was to present a new and straightforward technique (exchange-free technique [eft]) to enhance apposition of the surpass flow diverter (sfd), the only over-the-wire flow diverter currently available.  twenty-eight patients (20 females, 8 males, average age49 years old) with 30 treated aneurysms were identified.The mean aneurysm diameter was 10.2 ± 6.6 mm.Technical success rate was 96.6% (29/30 aneurysms).There was no mortality or permanent morbidity related to the procedures.Except for the patient treated for an iatrogenic, surgery-related internal carotid artery pseudoaneurysm who died secondary to consequences of multiple surgeries, no cases of mortality or permanent morbidity were noted.Complete aneurysm occlusion rates were 78.2%, 82.1%, and 95.2% at 0¿3, 3¿6, and 9¿12 months, respectively.None of the patients were re-treated.None of the patients had clinically significant thromboembolic or hemorrhagic complications after discharge.The patient with iatrogenic pseudoaneurysm was brought directly to the angiography suite from the operating room where she was having a transsphenoidal surgery.The patient had a lacerated ica for which endovascular treatment was performed.After treatment and past the acute period, the patient underwent multiple transsphenoidal surgeries due to extensive involvement of the skull base with carcinoma.The patient died 53 days after the endovascular procedure secondary to postoperative sepsis.Otherwise, there were no permanent morbidity, mortality, or bleeding complications.  eft is a simple and fast technique which was not associated with adverse effects in our series.The higher aneurysm obliteration rate obtained with eft is probably the result of better wall apposition of the sfd.  there were no device issues reported relating to the use of the navien or echelon microcatheter.  adverse events included: 1.Sepsis 2.Death.

• Brand Name: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16480917
• MDR Text Key: 310642946
• Report Number: 2029214-2023-00404
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ECHELON
• Device Catalogue Number: UNK-NV-ECHELON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2023
• 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): Death; Other
• Patient Age: 49 YR
• Patient Sex: Female