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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-400-20
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for analysis. Since the device was not returned, we are unable to perform further root cause analysis. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the pipeline flex device' pushwire broke. The patient underwent embolization treatment for a unruptured amorphous supraclinoid internal carotid artery (ica), measuring 6mmx4mm, landing zone distal 3. 5mm proximal 3. 7mm. The vessel was observed normal tortuous. It was reported that catheter was flushed and prepared as per instructions for use (ifu). It was delivered to the desired location without any trouble. Ped-400-20 (ped) was advanced into the microcatheter. It was pushed well without any resistance, it was then attempted to be deploying but the operator was not happy with the opening hence tried to resheathed it with the microcatheter. Resistance was felt and all of a sudden pipeline pusher wire was moving freely into the catheter. The complete system was taken out to inspect. It was found that the distal portion of ped was broken and the catheter distal part was stretched. No patient symptoms or complications were associated with this event. Dual antiplatelet treatment was administered. Pru level was 157. The catheter was flushed as indicated per the ifu. The post procedure angiography results show successful deployment of another ped.
 
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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 Key9450654
MDR Text Key194321907
Report Number2029214-2019-01217
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/16/2021
Device Model NumberPED-400-20
Device Catalogue NumberPED-400-20
Device Lot NumberA725130
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/17/2018
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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