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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-12
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Aneurysm (1708)
Event Date 06/29/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the first pipeline (model: ped-450-14, lot: b082276) was delivered but failed to open at the distal end when more than 50% deployed. The pipeline was resheathed 2 or less times. No other techniques or devices were tried to open the pipeline. The physician attempted to resheath the pipeline to remove but the ptfe sleeve seemed to be stuck on the phenom 27 microcatheter so the microcatheter and pipeline were both removed together and replaced. An attempt was then made to implant a pipeline (model: ped-450-18, lot: b084497). During advancement through the internal carotid artery (ica), the phenom 27 microcatheter jumped back. It was thought this may possibly have been due to lack of sufficient support from the intermediate catheter. The pipeline failed to open when less than 50% was deployed. The pipeline was resheathed 2 or less times.  no other techniques or devices were tried to open the pipeline. The pipeline was not positioned in a vessel bend. The pipeline was resheathed and removed. A pipeline (model ped-450-12) was then used and opened successfully but was too short and did not cover the aneurysm neck. A fourth pipeline (model: ped-475-14, lot: b031754) was then tried but would not open distally within the already implanted ped-450-12. The ped-475-14 was less than 50% deployed when the failure to open occurred. The pipeline was resheathed more than 2 times without opening successfully.  no other techniques or devices were tried to open the pipeline. It was resheathed and removed with the microcatheter. The patient was undergoing a flow diverter implantation procedure to treat an unruptured saccular aneurysm in theleft internal carotid artery (ica). The aneurysm max diameter was 3mm and the neck diameter was 2mm. Vessel tortuosity was moderate. Post-procedure angiography showed the single pipeline was was deployed. The patient had no related symptoms or complications.
 
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Brand NamePIPELINE FLEX
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 Key12143650
MDR Text Key261693429
Report Number2029214-2021-00843
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-12
Device Catalogue NumberPED-450-12
Device Lot NumberB085470
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 Received07/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/14/2020
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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