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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
Model Number NV UNK PIPELINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Nausea (1970); Visual Disturbances (2140); Ptosis (2620)
Event Date 01/25/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Capocci r, shotar e, di maria f, et al. Delayed treatment (
=
5 days) by flow diversion of ruptured blister-like cerebral aneurysms: case series of 8 consecutive patients. Clinical neuroradiology. 2020;30(2):287-296. Doi:10. 1007/s00062-019-00758-4. Medtronic literature review found a report of patient complications in associated with pipeline embolization device flow diverter stent. The purpose of this article was to evaluate the safety and effectiveness of a delayed (
=
5 days) flow diversion strategy for the treatment of ruptured intracranial blister-like aneurysms (blas). The authors reviewed 9 cases of blas in 8 patients. The study consisted of 2 men and 6 women with a mean age of 52 ± 8. 9 years and range of 39¿69 years. Six of the patients were implanted with a pipeline embolization device, and the other two patients were implanted with a stryker surpass stent. Most of the patients (5/8; 62. 5%) had an mrs <(><<)>2 at discharge. The immediate periprocedural control angiogram showed a complete exclusion of the aneurysm in one patient (12. 5%) but at follow-up (mean delay
=
19. 8 months) all patients had a complete aneurysm occlusion. All patients had a long-term mrs <(><<)>2. The article does not state any technical issues during use of the pipeline. The following intra- or post-procedural outcomes were noted: one patient had a major complication consisting of an acute ischemic stroke. No in-stent thrombus was observed on the immediate post-stent deployment dsa. As they emerged from general anesthesia, the patient complained of diplopia and nausea and had bilateral ptosis. An mri was immediately performed and revealed multiple infarcts in the cerebellum, thalami and medulla oblongata on diffusion weighted imaging (dwi) and mra showed an occlusion of the proximal right pca (p1 segment), which was supplied by a patent ipsilateral posterior communicating artery. The patient¿s condition gradually improved within a few weeks with a bilateral oculomotor and facial nerve palsy and a minor cerebellar syndrome at discharge. At last follow-up (65 months) only a minor cerebellar syndrome remained in this patient.
 
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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 Key10998589
MDR Text Key221278529
Report Number2029214-2020-01288
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
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 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
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: 12/13/2020 Patient Sequence Number: 1
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