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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX WITH SHIELD INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX WITH SHIELD INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-500-14
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2018
Event Type  malfunction  
Manufacturer Narrative
The device involved in the event has not been returned for evaluation; therefore, the event cause could not be determined. Correspondence has been sent out for the device. Once we received the device and the evaluation has been completed, a supplemental report will be submitted. For the other device: reference mdr # 2029214-2018-00445 if information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during and embolization treatment of an unruptured saccular aneurysm measuring in 8mm x 5mm located in the left internal carotid artery (ica) with severe tortuosity, two medtronic flow diverters could not be opened in the distal segments (the middle and proximal segments were open). The flow diverters were not positioned on a bend during the time of the event. The patient was on dual antiplatelet therapy (dapt). Both flow diverters were deployed approximately less than 50% when the failure occurred, and they were resheathed 1-2 times each. The physician attempted to open the distal segments by maneuvering the medtronic microcatheter and flow diverters until the flow diverters experienced resistance in the distal segment of the microcatheters and became trapped in the distal segment of the microcatheters. Both the flow diverters were resheathed and removed with the microcatheters from the patient. No patient injury was reported as a result of the procedures. The distal and proximal landing zones were 4. 8mm x 4. 8mm and the access vessel was the left ica with diameter of 4. 8mm.
 
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Brand NamePIPELINE FLEX WITH SHIELD
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7535040
MDR Text Key108987960
Report Number2029214-2018-00444
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 01/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/24/2020
Device Model NumberPED2-500-14
Device Lot NumberA466075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/25/2017
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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