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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-500-35
Device Problems Unintended Ejection (1234); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/08/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline flex with shield that failed to open in the middle and then became stuck and deployed in the hub of the phenom microcatheter. The patient was undergoing a procedure to treat an unruptured saccular aneurysm of the left internal carotid artery (ica) cavernous segment. The aneurysm max diameter was 11mm and the neck diameter was 7mm. Vessel tortuosity was severe. Dual antiplatelet treatment (dapt) was administered. It was reported that the pipeline and all accessory devices were prepared as indicated in the instructions for use (ifu). During dep loyment, the middle section of the pipeline was not opening. Resheathing was tried but the pipeline still did not open. It was noted the middle of the pipeline was positioned in the vessel cavernous bend. The pipeline was resheathed 2 or less times. When resheathing into the delivery sheath, the pipeline got stuck in the phenom catheter hub and deployed in the catheter hub. The device was removed and a competitor's device was then used to complete the procedure. There were no patient symptoms or complications associated with the event. Post-procedure angiography was uneventful.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key12469053
MDR Text Key271536274
Report Number2029214-2021-01164
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P100018.S033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-35
Device Catalogue NumberPED2-500-35
Device Lot NumberB158729
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 Received09/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/09/2021
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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