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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-375-12
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2020
Event Type  malfunction  
Manufacturer Narrative
The device has been received; however, the analysis has not been completed. The cause of the reported event has not been determined at this time. Once the analysis has been completed, a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the distal tip of the delivery wire of the medtronic flow diverter separated, and detached at the solder joint post successful deployment. The devices were prepared and use per the instructions for use (ifu). The angiographic result post the procedure showed the ped-375-20 correctly and successfully placed over medium sized wide-necked aneurysm in the left internal carotid artery at the terminus segment. The patient was doing well post procedure. The medtronic catheter and delivery wire with detached tip of the flow diverter device will be returned for analysis. The patient underwent treatment of a left internal carotid artery (ica), at the level of the terminus segment of the ica, unruptured, saccular aneurysm. The max diameter was 4 mm x 4 mm and the neck was 3 mm. The distal landing zone was 4 mm and the proximal was 5 mm. The vessel anatomy was minimal in tortuosity.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
9496801345
MDR Report Key9729111
MDR Text Key198537550
Report Number2029214-2020-00154
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-375-12
Device Lot NumberA848725
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/15/2019
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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