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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-450-16
Device Problem Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2019
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex has not been returned for evaluation; product analysis cannot be performed.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this event: 2029214-2019-01187 and 2029214-2019-01188.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report of pipeline flex incomplete opening during a procedure.Information that pipeline flex device flattened and stretched during the procedure.The pipeline did not open.Fistula happened during advancement of the navien and phenom 027 in an attempt to open the flattened area.The patient was undergoing embolization treatment for an unruptured amorphous aneurysm located in right internal carotid artery (ica) landing zone distal 3.2mm proximal 4.7mm.The vessel was observed moderately tortuous.It was reported that pipeline was prepped per ifu, no issues during deployment.Pipeline did appear to be stretching before detachment and was detached over a bend which resulted in flattening of the device.The physician advanced a guide catheter and microcatheter to open the flattened area.A run with contrast revealed a fistula that the physician believes was catheter induced.The physician decided to ¿sack¿ the vessel as the right ica on imaging was being well fed from contralateral flow.Right ica was sacrificed; the patient¿s contralateral flow was feeding right circulation.There were no patient symptoms or complications associated with this event.
 
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Brand Name
PIPELINE FLEX
Type of Device
INTRACRANIAL 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 Key9407255
MDR Text Key208856954
Report Number2029214-2019-01186
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00847536016415
UDI-Public00847536016415
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 Physician
Type of Report Initial
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/17/2021
Device Model NumberPED-450-16
Device Lot NumberA662356
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/12/2019
Initial Date FDA Received12/03/2019
Date Device Manufactured06/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age73 YR
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