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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paresis (1998); Thrombosis (2100); Visual Impairment (2138); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis as it was implanted in the patient. Thrombus formation is a known inherent risk of endovascular procedure and is documented in our device¿s instruction for use (ifu). Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received the following reports through literature review of ¿endovascular treatment of posterior cerebral artery aneurysms with flow diversion: case series and systematic review¿ (adam n. Wallace, jonathan a. Grossberg, josser e. Delgado almandoz, mudassar kamran, dphil, anil k. Roy, yasha kayan, matthew j. Austin) the study included 10 pca aneurysms in 9 patients (3 men, 6 women) with a mean age of 56 yr (range, 18¿74 yr). In patient 5, (b)(6) years female with a medium-size pcoa artery arising from the neck of a p1 aneurysm did not fill from the pca on follow-up angiography. Patient 7: (b)(6)-yr-old female with incidental 6-mm fusiform left p1-p2 aneurysm verify now testing (accumetrics) on the day of the procedure returned 256 prus, prompting an additional 300 mg pre-procedure loading dose of clopidogrel. Nonocclusive thrombus formed in the distal ped immediately after deployment resulting in slow antegrade flow to the right pca and both scas, all of which were covered by the ped. Approximately 30 min after intra-arterial infusion of abciximab (0. 20 mg/kg), flow to the covered branch vessels normalized. Intravenous heparin infusion (600 units/h) was continued for 12 h, post-procedure. The patient awoke from anesthesia neurologically intact and magnetic resonance imaging (mri) showed no acute infarct. The clopidogrel dosage was increased to 150 mg daily, and verify now testing returned 185 prus prior to home discharge. Patient 8: (b)(6)-yr-old female with incidental 13-mm saccular right p1-p2 junction aneurysm verify now (accumetrics) testing on the day of the procedure returned 138 prus. Since the patient had bilateral ica occlusions due to atherosclerotic disease, with the anterior circulation entirely supplied by the right pcoa, the ped was placed from the right pcoa into the basilar artery. Immediate post-procedure angiography showed no evidence of thrombus formation or distal vessel occlusion. However, the patient awoke from anesthesia obtunded with left hemiplegia. Immediate dsa showed thrombus within the ped and slow flow to both pcas and scas, all of which were covered by the ped. Flow normalized approximately 40 minutes after intra-arterial infusion of abciximab (0. 20 mg/kg). The patient improved clinically but had a persistent left visual field cut and short-term memory deficits. Mri showed extensive right pca territory infarction. The patient was discharged to a rehabilitation facility with and mrs of 3. Patient 3: (b)(6)-yr-old male with 11-mm wide, 45-mm long right p2-p3 fusiform aneurysm. This patient with a history of moyamoya disease and multiple previous strokes presented with hydrocephalus and brainstem compression. Both icas were occluded and the anterior circulation was predominantly supplied by pca branches distal to the aneurysm. A ventriculoperitoneal shunt was placed prior to beginning dual antiplatelet therapy and subsequent ped treatment of the aneurysm with 2 overlapping devices, after which the presenting symptoms stabilized. Dual antiplatelet therapy was maintained for 12 mo after treatment. However, the ped construct thrombosed 24 months post-procedure after clopidogrel was discontinued. Over a matter of days, the patient declined to an mrs of 5 from a preoperative baseline of 4.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8775466
MDR Text Key150541163
Report Number2029214-2019-00707
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 health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2019
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 Received06/17/2019
Was Device Evaluated by Manufacturer? No
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: 07/10/2019 Patient Sequence Number: 1
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