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); Paralysis (1997); Vasoconstriction (2126)

Event Date 12/25/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that during stent assisted coiling, a coil that was advanced inside an echelon microcatheter ruptured the aneurysm wall.Additional information was required to determine the cause of the event.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: 2029214-2020-00802.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic found through literature review that a (b)(6) year old female had complication of aneurysm rupture during stent assistant coiling embolization procedure that each involved an echelon 10 microcatheter.The patient presented with sudden headache and left oculomotor nerve palsy.The patient had rupture of ophthalmic arterial segment and posterior communicating segment aneurysms of the left internal carotid artery (ica).Dsa also indicated aneurysms in the posterior communicating segment of the right ica and severe stenosis in the terminal section of the right common carotid artery (cca).The patient was treated in two stages each five months apart.The first procedure was successful, but patient had incomplete paralysis in the left oculomotor nerve.The second procedure was done for the aneurysms in the right ica using lvis stent, echelon 10 with modified tip, and unknown coils.Upon placement of the third coil, the aneurysm wall ruptured as the coil went through the aneurysm wall.Extravasation was seen.The rupture was treated with detaching more coils through the echelon and injection of 2ml of ltp solution.Patient had subarachnoid hemorrhage (sah) with fisher grade 3 post procedure.Next day, patient underwent lumbar cistern drainage through catheter to prevent vasospasm and control elevated pressures.Patient had gch score of 13.30 days later, patient had gcs score of 15 and no signs of the sah.

• 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: 10412818
• MDR Text Key: 203360216
• Report Number: 2029214-2020-00801
• 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,literature
• 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: 78 YR