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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-475-14
Device Problem Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/07/2020
Event Type  malfunction  
Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. Reference mdr# for the other device: 2029214-2020-00812. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that two medtronic flow diverters could not be open despite multiple attempts with different techniques. They were removed and replaced with new medtronic flow diverters to complete the procedure. No patient injury was reported as a result of the event. It was noted that proctor and physician had exhausted all possible ways to try to get the devices to open. The flow diverters were replaced with shorter flow diverters. There were only long flow diverters available at the time of the procedure. The patient outcome was said to be fine. The physician believed that the flow diverters would not open due to their lengths (too long) and the patient¿s tortuous anatomy. The patient was undergoing embolization treatment of a unruptured saccular aneurysm measuring 15mm x 4mm located in the right internal carotid artery (ica). The distal and proximal landing zone was 4. 44mm x 4. 68mm. The vasculature was severe in tortuosity. There were no patient symptoms or complications associated with the event. The patient was on dual antiplatelet therapy. The pru level was 140. There are images for review attached to file. The patient¿s blood flow was normal. The vasculature was normal in tortuosity. Post procedural angiography results were fine.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10419074
MDR Text Key203292493
Report Number2029214-2020-00813
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 11/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/09/2022
Device Model NumberPED-475-14
Device Catalogue NumberPED-475-14
Device Lot NumberA861757
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/19/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/10/2019
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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