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 Confusion/ Disorientation (2553)

Event Date 07/28/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Kubilay aydin, paul stracke, mynzhylky berdikhojayev, mehmet barburoglu, pascal j.Mosimann, nurzhan suleimankulov, marat sarshayev, serra sencer, rene chapot.Neurosurgery, 2021, 88:1028¿1037, safety, efficacy, and durability of stent plus balloon-assisted coiling for the treatment of wide-necked intracranial bifurcation aneurysms.Doi:10.1093/neuros/nyaa590.Medtronic literature review found report of patient complications in association with stent plus balloon-assisted coiling procured using echelon 10 microcatheter, hyperglide balloon, and solitaire sent.The purpose of this study is to investigate how wide-necked bifurcation aneurysms can more effectively be treated. stent plus balloon-assisted coiling is a recently described endovascular technique that enables the coiling of wide-necked complex bifurcation aneurysms by implanting only a single stent. in this technique, a single stent is implanted into one of the side branches, and the other side branch of the bifurcation is protected by temporary inflations of a balloon catheter during coiling.61 patients were treated with a mean age of 54.6  years old.43 female, 18 male.2patients were treated using the solitaire and 17 were treated using the hyperglide. follow-up magnetic resonance angiography was performed 3 to 6 mo after the procedure.The first dsa follow-up was performed 9 to 18 mo after the procedure.One patient treated with the solitatie developed a subarachnoid hemorrhage (fisher grade 2) and a headache.Mrs at discharge is 1.Least mrs is 0. the final follow-up angiography revealed complete occlusion of the aneurysm in 49 patients (89.1%) and neck filling in 5 patients (9.1%) and recurrent sac filling in 1 patient (1.8%).The follow-up dsa showed a recanalization in 4 patients (7.3%). in 3 patients, the recanalized aneurysm necks remained stable at the consequent angiographic follow-ups and did not require retreatment.One patient required additional stent treatment.

• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12528032
• MDR Text Key: 273758557
• Report Number: 2029214-2021-01200
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2021

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
• Initial Date Manufacturer Received: 09/16/2021
• Initial Date FDA Received: 09/24/2021
• 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): Required Intervention