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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Arrhythmia (1721)
Event Date 01/04/2019
Event Type  Injury  
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 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.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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 Key8364185
MDR Text Key136983227
Report Number2029214-2019-00131
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
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 Received02/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/25/2020
Device Model NumberPED-400-16
Device Lot NumberA482129
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/26/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/22/2019 Patient Sequence Number: 1
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