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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX WITH SHIELD INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX WITH SHIELD INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-350-30
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2019
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 receive report that after the uneventful navigation and deployment of the pipeline flex, when an attempt was made to raise microcatheter to collect the sleeve. The delivery pusher was unable to be pulled in the middle. The delivery pusher was pulled, and movement of the wire could not be found, so it was judged that the wire had broken. However, the delivery pusher was almost retracted in microcatheter, and the delivery pusher was pulled out together with marksman. The delivery pusher was removed from microcatheter outside the body, and the breakage was confirmed visually. The break was in the proximal section of the pushwire. There was no resistance felt during the use of the devices. This event occurred during the treatment of an ica-cs that was not ruptured. The max diameter was about 15mm with a neck width of 5mm. The distal landing zone was 3. 4mm and the proximal was 4. 5mm. The anatomy was moderate in tortuosity. There was no patient injury. There are no images. The devices were prepared and used per the instructions for use (ifu).
 
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Brand NamePIPELINE FLEX WITH SHIELD
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 Key8893315
MDR Text Key154412799
Report Number2029214-2019-00842
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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 10/08/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-350-30
Device Lot NumberA821016
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2019
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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