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

Model Number FA-55150-1030

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

Patient Problem Cardiac Arrest (1762)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

The marksman catheter was not returned; product analysis could not be performed.The article states that the carotid sinus reflex was triggered when the navien and marksman were pushed farther to promote adequate opening and apposition of the ped.One of the main triggers of the carotid sinus reflex can be is stretching of the carotid sinus baroreceptor during use of a self-expanding stent.The investigation determined that the cause of the event was not related to a product technical issue.Mdrs related to this article: 2029214-2019-00131, 2029214-2019-00132.If information is provided in the future, a supplemental report will be issued.

Event Description

Goto, s., izumi, t., nishihori, m., ishida, m., ishida, t., otawa, m.,.Wakabayashi, t.(2019).Cardiac arrest induced by carotid sinus reflex activation during flow-diverter stent deployment.World neurosurgery, 124, 22-24.Doi: 10.1016/j.Wneu.2018.12.136.Medtronic literature review found a report of cardiac arrest during pipeline flex implantation.The patient was undergoing pipeline implantation in the retreatment of multiple aneurysms in the internal carotid artery (ica).The aneurysm had been coiled 6 months prior.It was reported that during the procedure, the marksman was triaxiality advanced through a 5-french navien.The navien was placed in the cavernous segment of the ica, and the marksman was then navigated to the second segment of the middle cerebral artery.The patient¿s blood pressure and heart rate at that time were 110/70 mm hg and 66 bpm, respectively.A pipeline flex was inserted and deployed from the proximal end of the ica posterior communicating artery bifurcation.During the deployment, cardiac arrest occurred when the navien and marksman were pushed farther to promote adequate opening and apposition of the ped against the vessel wall and increase the neck coverage by the device.Immediately before the arrest, the patient's blood pressure and heart rate were 90/50 mm hg and 60 bpm, respectively.By pulling the delivery system back down and reducing tension to the carotid sinus, a normal sinus rhythm was immediately restored; the cardiac arrest lasted approximately 30 seconds.The procedure resumed after administration of intravenous atropine (0.5 mg), with care not to excessively push the system.Neither severe hypotension nor bradycardia were observed for the remainder of the procedure, and after successfully deploying the ped, a postoperative neurologic examination was negative.The patient was discharged on postoperative day 4.

• Brand Name: MARKSMAN
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 7635263305
• MDR Report Key: 8364222
• MDR Text Key: 136987682
• Report Number: 2029214-2019-00133
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091559
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FA-55150-1030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2019
• 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
• Patient Age: 60 YR