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 Intracranial Hemorrhage (1891); Nerve Damage (1979); Perforation (2001); Unspecified Nervous System Problem (4426); Swelling/ Edema (4577)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

Reported patient age (47 years) is representative of the mean age for all patients included in the study.Reported patient sex (female) is representative of the majority (69.2%) of patients included in the study.If information is provided in the future, a supplemental report will be issued.

Event Description

Zhao x, wang x, wang m, meng q, wang c.Treatment strategies of ruptured intracranial aneurysms associated with moyamoya disease.British journal of neurosurgery.35:2, 209-215, doi: 10.1080/02688697.2020.1781058.The purpose of this article was to present our experience in the management of ruptured intracranial aneurysms associated with moyamoya disease (mmd), and to discuss their treatment strategies and the timing of revascularization surgery.106 adult patients who were diagnosed with hemorrhagic mmd between february 2012 and may 2019.The diagnosis of mmd was made by angiographic findings based on the 2012 guidelines for mmd.3 patients with moyamoya syndrome secondary to the identified etiologies were ruled out.Among these hemorrhagic mmd patients, 13 patients had ruptured intracranial aneurysms causing intracranial hemorrhage.Clinical presentation included subarachnoid hemorrhage (sah) in 11 patients, intraventricular hemorrhage (ivh) in 1, intracerebral hemorrhage (ich) with ivh in 1.Of the 13 patients, the average age was 47 years, 9 were female and 4 were male.  the following intra- or post-procedural outcomes were noted: right hemiplegia and aphasia occurred in one patient (case (b)(6)) with an anterior communicating artery (acoa) aneurysm after surgical clipping through a left pterional approach.This patient had cerebral swelling.Complications were also related with intraoperative injury to the collateral vessels around the aneurysm.Recurrent intracranial hemorrhage occurred 2 years after the operation in a patient (case (b)(6)) with a right pca aneurysm which had been clipped without revascularization.Two patients had moderate or severe neurological deficits (mrs score 3 ¿5) due either to surgical complications or to brain damage caused by the recurrent intracranial hemorrhage.

• 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: 13559230
• MDR Text Key: 289198790
• Report Number: 2029214-2022-00226
• 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
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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
• Date Manufacturer Received: 01/26/2022
• 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): Other
• Patient Age: 47 YR
• Patient Sex: Female