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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-400-18
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the distal end of the pipeline did not open normally after being deployed about 10 mm. The problem could not be resolved after adjustment. The physician withdrew the stent, and it was found that the tip was damaged. A replacement device was used to complete the procedure. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-procedure angiography showed good blood flow. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the ophthalmic artery with a max diameter of 4. 62 mm and a 4 mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered. Ancillary devices include a 6f envoy guidecatheter, marksman 150 microcatheter.
 
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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 Key10840616
MDR Text Key216348628
Report Number2029214-2020-01128
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 company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-18
Device Catalogue NumberPED-400-18
Device Lot NumberB047665
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2020
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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