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 Problems Headache (1880); Intracranial Hemorrhage (1891); Rupture (2208)

Event Date 11/17/2021

Event Type  Death  

Event Description

Haishuang tang, chenghao shang, guanghao zhang, qiao zuo, xiaoxi zhang, fengfeng xu, yi xu rui zhao, qinghai huang, qiang li, jianmin liu; neuroradiology; 2022: 64:1847¿1856; braided stents assisted coiling for endovascular management of posterior cerebral artery aneurysms: a preliminary mid-term experience; https://doi.Org/10.1007/s00234-022-02956.Medtronic received information that some patient's possibly treated with an echelon-10 catheter possibly had compilations.  posterior cerebral artery (pca) aneurysms are rare.The study was to evaluate the preliminary experience of braided stents applied in pca aneurysms treatment.  angiographic and clinical data of 28 pca patients treated with braided stents from july 2016 and september 2020 were retrospectively analyzed.The echelon was one of three catheters used to deliver the coils in the study. coiling embolization of pca aneurysm was conducted and the braided stent was deployed in pca aneurysm neck to avoid coil protruding into aneurysm patent artery.Stent semi release or post-release technology was adopted following different morphologies and locations of pca aneurysms.All braided stents were deployed under the standard manner recommended by the manufacturer.Antiplatelet treatment was administered.Perioperative hemorrhagic events occurred in 1 patient.This patient was a 48-year-old man who was diagnosed with a ruptured dissecting aneurysm located in right p2 segment. this patient experienced persistent headache on the first postoperative day, and an emergency ct scan revealed hemorrhage located in the right cerebral peduncle and brain stem. pao and external ventricular drainage surgery was subsequently performed, the patient¿s mrs score was 5 when discharging, and clinical follow-up confirmed the death event 2 weeks.No other procedure-related events (including ischemic events, contrast agent encephalopathy, etc.) occurred in this research.

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.

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

Additional information received reported that the events were not directly related to medtronic products.

• 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: 15859690
• MDR Text Key: 304273943
• Report Number: 2029214-2022-01997
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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 Model Number: UNK-NV-ECHELON
• Device Catalogue Number: UNK-NV-ECHELON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 12/05/2022
• Supplement Dates FDA Received: 12/13/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Female