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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-450-20
Device Problems Break (1069); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/27/2019
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 information that a pipeline flex pushwire broke. The patient was undergoing embolization treatment for a medium unruptured amorphous right supraclinoid aneurysm. Measuring 15mmx6mmm, landing zone distal 3. 50mm proximal 4. 25mm. The vessel was observed minimal tortuous. Reported device and any accessory devices were prepared as indicated in the ifu. It was reported that pipeline device had been partially delivered, resheathed, then removed from the patient due to a loss of access. The system was removed from the patient. On the back table, while pulling the pipeline out of the catheter, the lead wire of the pipeline delivery wire broke off. There were no patient symptoms or complications associated 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
9496801345
MDR Report Key9084672
MDR Text Key180588469
Report Number2029214-2019-00935
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/30/2020
Device Model NumberPED-450-20
Device Lot NumberA517431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2017
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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