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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-450-25
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the first pipeline was deployed successfully; however with the same microcatheter, the second pipeline could not be opened well at the contralateral aneurysm, but it was still used. It was stated that there was catheter resistance in the distal section of the microcatheter. It was indicated that there was patient injury details of an aneurysm; however, the patient was being treated for a cerebral vascular aneurysm. The access vessel was the internal carotid artery ophthalmic artery segment, and its vessel diameter was 4. 24mm. It was noted the vessel tortuosity was moderate. There were no patient symptoms associated with the event. The devices were prepared as indicated in the ifu. Anxillary device: 6f 115cm navien guide catheter, marksman microcatheter.
 
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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 Key11755684
MDR Text Key248835409
Report Number2029214-2021-00518
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-25
Device Catalogue NumberPED-450-25
Device Lot NumberB125897
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 Received04/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/02/2020
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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