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 Hemorrhage, Subarachnoid (1893); Vasoconstriction (2126)

Event Date 12/25/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that during treatment of aneurysm, an echelon 10 was advanced to the aneurysm and when the tip was introduced into the neck of the aneurysm, heart rate and blood pressure increased.Angiography showed extensive extravasation.The corresponding author was contacted to obtain additional event details.However, no response was received from the author.As the device was still in use at the time this investigation was completed, no analysis could be performed.There was no indication that the event was related to a potential manufacturing issue and no dhr was requested, so a device history record review was not performed.Hemorrhage is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).However, the exact cause of the reported adverse event remains unknown.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Monitoring and trending this type of event.The investigation determined that this was a known event, and therefore no new formal investigation was required.Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file.Jiang c, wang w, wang b, et al.Lyophilizing thrombin powder-based treatment for hemostasis during coil embolization of ruptured cerebral aneurysm: two case reports.Interventional neuroradiology journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences.2019;25(4):454-459.Doi:10.1177/1591019918824866.Reference mdr# for other patient: 2029214-2020-00801.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic found through literature review that a 64 year old female had complication of aneurysm rupture during treatment of aneurysm.The echelon 10 was advanced to the aneurysm and when the tip was introduced into the neck of the aneurysm, heart rate and blood pressure increased.Angiography showed extensive extravasation.Coils were delivered as treatment, but dsa showed massive bleeding and over flow from aneurysm to right lateral fissure and temporal lobe.This caused resistance prevent coils from entering aneurysm sac.Coiling was stopped and echelon 10 was used to inject three aquilots of 2.5ml of ltp solution.The bleeding was reduced after 3rd treatment at which more coils were placed in aneurysm.Ct showed right lateral fissure and temporal lobe hematoma along with sah.After procedure, patient underwent lumbar cistern drainage through catheter to prevent vasospasm and control elevated pressures.On day 90, the gcs score was 15 and mrs score was 4.The mrs on follow-up at one year was 3.

• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 10412817
• MDR Text Key: 206960845
• Report Number: 2029214-2020-00802
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• 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 Lot Number: NOT-REP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• 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; Disability
• Patient Age: 64 YR