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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); Intracranial Hemorrhage (1891); Loss of Vision (2139)
Event Date 06/20/2020
Event Type  Injury  
Manufacturer Narrative
The patient reported age of 50 is representative of the mean patient age for all patient included in the literature article study. A3. The reported patient gender of "male" is representative of the majority of patient in the literature article study (52%). A5b. The patient race "white" is representative of the majority of patients in the literature article study (72%). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Griffin, a. , lerner, e. , zuchowski, a. , zomorodi, a. , gonzalez, l. F. , hauch, e. F. (2020). Flow diversion of fusiform intracranial aneurysms. Neurosurgical review. Https://doi. Org/10. 1007/s10142-020-01332-0 abstract fusiform aneurysms are less common than saccular aneurysms, but have higher associated mortality and rebleeding rates. Recently, flow diversion has emerged as a possible treatment option. The purpose of this study was to determine the safety and efficacy of the pipeline embolization device (ped) for the treatment of ruptured and unruptured fusiform aneurysms. This was a retrospective analysis of patients with fusiform intracranial aneurysms treated with a ped at a quaternary care center between january 2012 and september 2019. Occlusion rates, neurologic morbidity/mortality, and other clinical variables were analyzed. Twenty-nine patients with 30 fusiform aneurysms were treated with a ped. Sixteen aneurysms (53%) were located in the anterior circulation and 14 aneurysms (47%) were in the posterior circulation. The mean maximal diameter of the aneurysms was 10. 1 ± 5. 6 mm (range 2. 3¿25 mm). Angiographic and clinical follow-up were available for 28 aneurysms (93%). The median follow-up was 17. 4 months (iqr 4. 8 to 28 months) and occlusion rates were graded according to the o¿kelly-marotta (okm) scale. Of patients with dsa follow-up, 15 aneurysms (60%) were completely occluded (okm d) and 19 aneurysms (76%) had a favorable occlusion result (okm c1-3 and d). The overall complication rate was 26. 7% with a neurological morbidity rate of 6. 7% and neurological mortality rate of 3. 4%. Flow diversion can be an effective treatment for both ruptured and unruptured fusiform aneurysms. Nevertheless, complete occlusion rates are lower than for saccular aneurysms. Therefore, flow diversion should be considered only if other more direct treatment options, such as clipping or stent/coiling are not applicable. Flow diversion should be used cautiously in patients presenting with rupture. It was reported that all procedures in the study were technically successful. No device malfunctions were reported. 3 patients experienced serious injury or complication related either to the device or procedure. 1 patient suffered brainstem stroke due to acute thrombosis. 1 patient experienced blindness. Another patient suffered an intraparenchymal hemorrhage after second procedure to place a ventriculoperitoneal shunt 7 days after placement of the pipeline; dual antiplatelet treatment (dapt) had been held and the patient had two units of platelets transfused prior to the shunt placement procedure. This patient made a full neurological recovery. 4 patient's required retreatment due to persistent aneurysm.
 
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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 Key11002629
MDR Text Key221284693
Report Number2029214-2020-01295
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 literature
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
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 NumberNOT-RPT
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 Received11/18/2020
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: 12/14/2020 Patient Sequence Number: 1
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