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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 Problems Activation, Positioning or SeparationProblem (2906); Material Deformation (2976)
Patient Problems Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event indicates article was published in the journal in september 2020. The exact date of publication was not specified. Procedures were completed between 2014 and 2018. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Cho, d. Y. , choi, j. H. , choi, h. S. , kim, b. , & shin, y. S. (2020). Immediate postoperative angiographic stagnation of contrast media and t2-weighted magnetic resonance imaging features within aneurysmal sac are associated with early regression of large or giant aneurysm after flow diversion only.  world neurosurgery, 141, e151¿e159. Https://doi. Org/10. 1016/j. Wneu. 2020. 05. 047 medtronic review of the literature article found 30 cases analyzed post-operatively with 3-6 months follow-up after implantation of pipeline embolization devices to treat cerebral aneurysms. The purpose of the study was to compare the imaging features from digital subtraction angiography (dsa) and spin echo t2-weighted magnetic resonance imaging (mri) between patients with early total regression and those with partial regression. All cases except 1 were considered successful. The single case that was considered to not be successful was because of incomplete apposition due to the stent kinking. Kinking also occurred in 3 other cases that were considered to be successful. Foreshortening was observed in 7 cases intra-operatively and for all cases with foreshortening, an additional pipeline was placed. 5 cases required a balloon to assist with wall apposition. Of the 30 patients included in the study, 10 showed only partial occlusion or aneurysm regression in the 3-6 month follow-up. These results were based on observation of the percent area of iodine stagnation dsa and measurement of the entire volume of the aneurysm sac in mri. It should be noted that contradictory information was seen in the article. Though the article states more than once that 20 patients had total or near total regression and 10 had partial regression, the information in table 1 is contradictory - indicating that 10 patients had total or near total regression and 20 had partial regression.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12159010
MDR Text Key261298859
Report Number2029214-2021-00853
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeKS
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 07/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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 Received06/26/2021
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

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