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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-400-25
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/19/2019
Event Type  Injury  
Manufacturer Narrative
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 report that the distal segment of the pipeline flex delivery system separated within the treating vessel. The separated distal segment was unable to be retrieved. During the release of the stent, the tip of coil and part of the pushing guide wire were disconnected from the pushing rod. The stent and the tip of development guide wire and part of the pushing guide wire remained in the body, which couldn't be removed. The surgeon tried to remove the broken guide wire with a gooseneck device and sab, a neurovascular remodeling device, but failed. Released the sab to cover the guide wire, and released a blood flow guide embolism device ped, successfully covered the aneurysm neck, aneurysm retention. The patient was asymptomatic post the intervention. This event occurred during the treatment of a c4, left internal neck aneurysm. The aneurysm was unruptured and saccular. The max diameter was 20mm and the neck was 8mm. The distal landing zone was 3. Omm and the proximal was 3. 5mm. The vessel anatomy was minimal in tortuosity. Ancillary devices: 6fr long sheath, 6fnavien115, marksman150; the devices were prepared and used per the instructions for use (ifu).
 
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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 Key9522099
MDR Text Key188883908
Report Number2029214-2019-01299
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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 02/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-25
Device Lot NumberA845208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/10/2019
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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