MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number UNK-NV-AXIUM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Toshinori matsushige, shigeyuki sakamoto, daizo ishii, katsuhiro shinagawa, koji shimonaga, masahiro hosogai, tomohiro kawasumi, junpei oshita, takahito okazaki and kaoru kurisu.Safety and efficacy of a new outreach distal access catheter, tactics, for coil embolization of unruptured intracranial aneurysms.Doi: 10.1177/1591019918774888.Medtronic literature review found a report of a patient complication after axium coil implantation.Current large-bore catheters can be easily and safely placed in the intracranial vessels for the stabilization of microcatheters in several neurointervention scenarios.We considered that a novel 3.4 french catheter (tactics, technorat corporation, aichi, japan) might be useful for intermediate/distal access in a triaxial system.Here, we present our initial experience using the tactics catheter for treatment of intracranial aneurysms.One patient in the control group developed transient ischemic attack (tia) after treatment.

• Brand Name: AXIUM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 9482628
• MDR Text Key: 173939449
• Report Number: 2029214-2019-01251
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-AXIUM
• Device Catalogue Number: UNK-NV-AXIUM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• 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