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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
Model Number NV UNK FLEX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Visual Disturbances (2140); Stenosis (2263)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
Wang t, richard sa, jiao h, li j, lin s, zhang c, wang c, xie x, you c. Institutional experience of in-stent stenosis after pipeline flow diverter implantation: a retrospective analysis of 6 isolated cases out of 118 patients. Medicine 2021;100:11(e25149) http://d x. Doi. Org/10. 1097/md. 0000000000025149. Age or date of birth: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Date of event: please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature. Refer to manufacturer report 2029214-2021-01108 for details pertaining to the related reportable event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Wang t, richard sa, jiao h, li j, lin s, zhang c, wang c, xie x, you c. Institutional experience of in-stent stenosis after pipeline flow diverter implantation: a retrospective analysis of 6 isolated cases out of 118 patients. Medicine 2021;100:11(e25149) http://d x. Doi. Org/10. 1097/md. 0000000000025149. Medtronic literature review found reported of patient complications in association with implantation of the flex pipeline embolization device (pled). Wall malapposition was observed in 2 patients. The purpose of this article was to identify patients with, in-stent stenosis (iss) after implantations of pipeline flex embolization devices as treatments for intracranial aneurysms. They observed 5% (6/118) incidence rate of iss in intracranial aneurysmal patients treated with pleds at the institution. The patients were made up of 2 males and 4 females with a mean age of 42. The following intra- or post-procedural outcomes were noted: dizziness. Blurring of vision severe stenosis. Wall malapposition was observed in 2 patients, which occurred in the distal segments of the icas.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12422423
MDR Text Key273788592
Report Number2029214-2021-01109
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNV UNK FLEX
Device Catalogue NumberNV UNK FLEX
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 Received08/05/2021
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

Patient Treatment Data
Date Received: 09/03/2021 Patient Sequence Number: 1
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