MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	PED-400-16
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The pipeline flex remains implanted in the patient; 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: 2029214-2019-00132, 2029214-2019-00133.If information is provided in the future, a supplemental report will be issued.
Event or Problem 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 triaxially 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: PIPELINE FLEX
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8364185
• Report Number: 2029214-2019-00131
• Device Sequence Number: 2307332
• Product Code: OUT
• UDI-Device Identifier: 00847536015876
• UDI-Public: 00847536015876
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100018.S011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2020
• Device Model Number: PED-400-16
• Device Lot Number: A482129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 02/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR