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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-400-18
Device Problems Break (1069); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2019
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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report of pipeline flex pushwire break during a procedure. The patient was undergoing embolization treatment for a flow diversion of a small unruptured saccular aneurysm located right internal carotid artery (ica) in c4-c5 segment. Measuring 5. 5mm4mm. Landing zone distal 3. 6mm proximal 4. 18mm. The vessel was observed severely tortuous. The devices were prepared as indicated in the ifu. A continuous flush was maintained during the procedure. It was reported that during the intervention, the pipeline flex was delivered to the distal section of the catheter. The pipeline flex was not able to be pushed from the catheter despite applying force. The catheter and pipeline flex were removed as a unit from the patient. After removal, the pipeline flex tip coil was observed to be broken. There were no reports of patient injury in association with this event.
 
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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
7635263305
MDR Report Key8862647
MDR Text Key179104532
Report Number2029214-2019-00814
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTW
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,Followup
Report Date 09/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-18
Device Catalogue NumberPED-400-18
Device Lot NumberA729553
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/19/2019
Was Device Evaluated by Manufacturer? Yes
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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