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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE; FLOW DIVERSION
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EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE; FLOW DIVERSION Back to Search Results
Model Number FA-77400-18
Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/04/2014
Event Type  malfunction  
Event Description
Treatment of a small aneurysm.On (b)(6) 2014, the patient underwent pipeline (4.00mm x 18mm) embolization treatment.During the procedure, it was reported the pipeline could not be released from the capture coil despite several attempts.The entire system (pipeline and catheter) were removed from the patient and the patient was treated another way.The patient is in fine condition.
 
Manufacturer Narrative
The device involved in the event has not been returned for evaluation.(b)(4).
 
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Brand Name
PIPELINE EMBOLIZATION DEVICE
Type of Device
FLOW DIVERSION
Manufacturer (Section D)
EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
henry to
9775 toledo way
irvine, CA 92618
9496801335
MDR Report Key3666798
MDR Text Key15270625
Report Number2029214-2014-00114
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 02/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/22/2016
Device Model NumberFA-77400-18
Device Lot Number9793355
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/23/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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