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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 No Apparent Adverse Event (3189)
Patient Problems Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Muscle Weakness (1967); Occlusion (1984); Visual Disturbances (2140); Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Enriquez-marulanda a, salem mm, ascanio lc, et al. No differences in effectiveness and safety between pipeline embolization device and stent-assisted coiling for the treatment of communicating segment internal carotid artery aneurysms.  the neuroradiology journal. 2019;32(5):344-352. Doi:10. 1177/1971400919845368. The aim of this study is to analyze pipeline angiographic and functional outcomes, and procedural complications. The average age was 61 years old, 80. 1% female. 21 patients in total were implanted with a pipeline device. Complete occlusion was achieved in 71. 4% of the procedures, and there were three patients who required retreatment with an additional pipeline placement. It was reported that one patient had extravasation intra-procedurally, which was controlled with onyx and an external ventricular drain (evd). However, this patient suffered a second frontal hemorrhage on removal of the evd but made a complete recovery. A second patient had a right occipital hemorrhage with transient visual disturbance 23 days post procedure, which resolved. A third patient presented with an acute subdural hematoma 1 day following implant, which was treated with urgent craniotomy. Post-operative complete occlusion of the ica occurred, while off antiplatelet therapy, but the patient underwent successful emergent thrombectomy. The patient suffered persistent aphasia and right sided weakness. The final patient was noted to have an intraprocedure thrombosis which was treated with eptifibatide, heparin, and a balloon assisted technique. On post-operative day 1, the patient presented with anomia and right monoparesis which progressively improved until discharge leaving persistent mild residual weakness. In total for the pipeline group there were three intracranial hemorrhagic complications, two thromboembolic complications, and four other procedural related complications.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9856581
MDR Text Key193407172
Report Number2029214-2020-00261
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
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 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
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 Received03/09/2020
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: 03/19/2020 Patient Sequence Number: 1
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