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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 PED2-500-20
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2019
Event Type  Injury  
Manufacturer Narrative
The device involved in the reported event has not been returned for evaluation; therefore, the event cause could not be determined. Correspondence has been sent out to the customer. Once the device has been received and the investigation has been completed, a supplemental report will be submitted. Reference mdr#: 2029214-2019-00649. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that middle segment of one medtronic flow diverter (5 x 25) did not fully open and another flow diverter (5 x 20) fell into the aneurysm. Prior to the event, the medtronic microcatheter was positioned distal to the aneurysm. An attempt was made to release the first flow diverter (5 x 25) and the reported event occurred. The flow diverter was replaced by another flow diverter (5 x 20) and during maneuvers to release the flow diverter, it fell into the aneurysm. A new flow diverter of the same size was used and implanted successfully. No patient injury was reported as a result of the event. The patient was undergoing embolization treatment of an unruptured saccular aneurysm (unknown measurements) located in the ophthalmic segment of the left internal carotid artery (ica). Patient was on dual antiplatelet therapy. Patient¿s vasculature was severe in tortuosity. No images for review.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8747171
MDR Text Key149632335
Report Number2029214-2019-00650
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2020
Device Model NumberPED2-500-20
Device Lot NumberA562313
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2017
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: 07/01/2019 Patient Sequence Number: 1
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