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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 05/29/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Mohammaden mh, english sw, stapleton cj, et al safety and efficacy of ticagrelor as single antiplatelet therapy in prevention of thromboembolic complications associated with the pipeline embolization device (ped): multicenter experience journal of neurointerventional surgery 2020;12:1113-1116. Medtronic literature review found reported of patient complications in association with flow diversion treatment with a pipeline. The authors reviewed 36 aneurysms of 24 patients treated for intracranial aneurysms treated with flow diversion (fd) using ticagrelo r. Of the 24 patients, the average age was 47. 7 years, 15 were female and 9 were male. Modified rankin scale scores were 0-2 for all patients upon discharge with the exception of one patient had a score of 6. The article does not state any technical issues during use of the medtronic device(s). 14 (58. 3%) patients presented with subarachnoid hemorrhage. 35 aneurysms arose from the anterior circulation and 1 from the posterior circulation. 23 aneurysms had a saccular morphology, whereas 7 were fusiform and 6 were blister. For the treatment of all 36 aneurysms, 30 procedures were performed with 32 fd devices. There were no reported early or late thromboembolic events. There were no cases of reported intraprocedural bleeding. At 6 month follow-up, angiography showed complete occlusion in 31 (91. 2%) aneurysms (figure 2) and subtotal filling in three (8. 8%) aneurysms. One of these aneurysms required retreatment at a 1 year follow-up with another ped, and the rest will be managed according to 1 year follow-up angiography as well.
 
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Brand NamePIPELINE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10916452
MDR Text Key218693801
Report Number2029214-2020-01199
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeEG
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 11/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received11/13/2020
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: 11/29/2020 Patient Sequence Number: 1
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