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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problems Positioning Failure (1158); Stretched (1601)
Patient Problems Cardiac Arrest (1762); Therapeutic Response, Decreased (2271); Loss Of Pulse (2562)
Event Date 10/16/2014
Event Type  Injury  
Manufacturer Narrative
The device involved in the event was not returned; therefore the cause of the event could not be determined. The pipeline was implanted in the patient and will not be returned. The microcatheter was not kept. The procedure was performed on patient with loeys-dietz syndrome and the chances for the adverse events to occur with the devices were more likely in this patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information through literature review that a 5mm x 18mm medtronic flow diverter was implanted in a patient to treat a large dyplastic aneurysm located in the cavernous segment of the internal carotid artery; however, there was not complete aneurysm coverage so the medtronic microcatheter was re-advanced over a guidewire and slack was pulled from the system in order to implant a second medtronic flow diverter. These actions caused the lower cervical loop to straighten out causing the patient to become asystolic for approximately 15 seconds. The guidewire was quickly withdrawn and then reloaded in the microcatheter which restored the cervical loop and the patient¿s normal cardiac rhythm was restored. The second medtronic flow diverter was implanted and post procedural angiography showed contrast stasis in the aneurysm. The purpose of the article was to point out that aneurysm treatment with a pipeline flow diverter can be a safe option for patients with loeys-dietz syndrome. Patient¿s with loeys-dietz syndrome have fragile vessels and there are higher chances of vessel dissection during intracranial procedures. Although the patient in the article became asystolic for 15 seconds, the patient was successfully treated with the pipeline device without causing any damage to the vessels. The asystole was caused by manipulation of the distal support catheter (navien) but the catheter helped to prevent vessel damage from manipulation of the pipeline because it limited any focused pressure that might be forced on the vessel wall. It is also noted that patient¿s with loeys-dietz are more prone to cardiac events. Colby gp, lin l-m, zeiler sr, et al. Curative reconstruction of a cerebral aneurysm by flow diversion with the pipeline embolisation device in a patient with loeys-dietz syndrome bmj case rep 2014. Doi:10. 1136/bcr-2014-204412.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine 92618
9492753836
MDR Report Key7708256
MDR Text Key114671814
Report Number2029214-2018-00636
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,litera
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
Device Lot NumberNOT-REP
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
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: 07/20/2018 Patient Sequence Number: 1
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