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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-450-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Neurological Deficit/Dysfunction (1982)
Event Date 03/11/2016
Event Type  Injury  
Manufacturer Narrative
The device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that a patient experienced mass effect after pipeline flex implantation. The patient underwent pipeline flex implantation in the treatment of a cavernous, left internal carotid artery (ica) aneurysm. The aneurysm max. Diameter was 22. 4 mm and neck width was 8. 9 mm. There were no reports of any device issues during implantation. One day post-intervention, mri image showed worsening mass effect. There was no medical intervention required. The patient is reportedly fine. There was no report of any neurological symptoms as a result of this event. The physician reports the issue was not related to the intervention or to the use of pipeline. The patient reportedly did not have mass effect prior to the procedure. Prior to intervention, the patient¿s mrs was 0. Post-intervention, mrs was 1. There was causal relationship with equipment and the mass effect deterioration. Severity: not serious. Outcome: recovery, outcome confirmation date: march 9, 2017.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10283907
MDR Text Key207917722
Report Number2029214-2020-00693
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/02/2018
Device Model NumberPED-450-20
Device Catalogue NumberPED-450-20
Device Lot NumberA156311
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 Received06/25/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/03/2015
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: 07/16/2020 Patient Sequence Number: 1
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