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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-400-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Air Embolism (1697)
Event Date 10/10/2019
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis as the device was implanted in the patient. 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. Thrombus formation is a known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu). Based on the reported information, there is no evidence suggesting that the device was defective, but rather a procedure related event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that after placement of the pipeline device, the physician opted to wait 10 minutes to ensure no clot formation on the device due to higher pru level. During this period, one of the flush bags ran out and air was introduced into the catheter and into the arteries. Upon angiography it was noted the lack of filling in the anterior cerebral artery (aca) which he believed to be due to an air embolism. The patient was reported to have possible experienced a right aca stroke due to the air embolism. The patient¿s pru level was 253. The pipeline was open with stagnation in the aneurysm. Partial aca blockage due to air embolism. This event occurred during the treatment of a right ica ophthalmic aneurysm that was unruptured. The morphology was saccular, the max diameter was 8mm and the neck was 4mm. The landing zone was 3. 8mm distally and the proximal was 4. 18mm. The vessel anatomy was moderate in tortuosity.
 
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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 Key9219942
MDR Text Key164846130
Report Number2029214-2019-01057
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
Report Date 10/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-400-16
Device Lot NumberA795848
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/10/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/22/2019 Patient Sequence Number: 1
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