MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 MARATHON; CATHETER, CONTINUOUS FLUSH

Model Number 105-5056

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Infarction, Cerebral (1771)

Event Date 11/10/2019

Event Type  malfunction  

Manufacturer Narrative

Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.No corrective action.Visual disturbance is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu).However, the exact cause for the adverse event and malfunction remain unknown.Linked mdrs: 2029214-2019-01131, 2029214-2019-01266, 2029214-2019-01267.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the patient developed a cerebral infarction a few days after medtronic liquid embolic embolization treatment.Prior to the event, the medtronic liquid embolic was injected from the distal end of the left pica.It was reported that there was difficulty removing the microcatheter because the tip was stuck.Once the catheter was removed, there was separation and movement of an medtronic liquid embolic lump.The patient was undergoing embolization treatment of an arteriovenous malformation (avm).The medtronic liquid embolic embolization was performed in the left pica, but the postoperative mri confirmed cerebral infarction in the pc area.This event occurred during the treatment of an arteriovenous malformation (avm), the feeder was severely tortuous.Onyx was injected at 0.25 / 90 seconds.It was reported that there was onyx reflux to the catheter, there was some resistance, but it was not hard to remove the catheter.Removal of nidus was performed.There was no vasospasm.Some left visual field disorder remained.The condition was not very good since bleeding occurred originally.The patient was planned to be transferred to a rehabilitation facility later.

• Brand Name: MARATHON
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9499151
• MDR Text Key: 209012959
• Report Number: 2029214-2019-01268
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/09/2021
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: A690033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: No
• 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