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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-500-25
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2020
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex pushwire was returned for evaluation without the braid or the microcatheter. The dps sleeves were found intact with no signs of damage. The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation. The pushwire appeared to be separated at the distal hypotube. The pushwire was found to be kinked at the distal tip coil. In addition, the pushwire was also found to be kinked near the proximal end. No damages were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper. No other anomalies were observed. The broken end will be sent out for sem/eds analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the pipeline flex (ped) pushwire separated during the intervention. The device and the separated piece were successfully removed from the patient. No patient injury occurred. The distal access catheter (dac) was placed high into the petrous internal carotid artery (ica) before bringing the microcatheter up into the m2 segment. After prepping the ped per the instructions for use, the ped was loaded into the microcatheter. Once it reached the ica resistance was felt. The ped was able to advance all the way to the end of the microcatheter but with great force. When attempted to unsheath and position the ped, it was noticed that the device was not responding to the wire anymore. It was then suspected that the pushwire fractured. The microcatheter, ped (partially opened) and the wire were removed as a unit back through the dac device and out of the patient. No ill effects on the patient were noted from these maneuvers. New devices were used to treat the patient. The compliant ped was reported to have locked up in the distal section of the microcatheter. The physician did release the load (slack) in the system to resolve the issue but failed. The catheter was not damaged but the pushwire was fractured at the resheathing pad. The ped was also reported not have opened at the distal section. The patient was treated for an unruptured right, ica, amorphous aneurysm. The max diameter was 8 mm with a neck diameter was 6 mm. The distal landing zone was 3. 5 mm and the proximal 5 mm. The vessel anatomy was severe in tortuosity.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9916773
MDR Text Key202551003
Report Number2029214-2020-00318
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-25
Device Lot NumberA845213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/12/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2019
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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