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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-500-25
Device Problem Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a pipeline flex which failed to open in the middle section. The patient was being treated for an unruptured amorphous aneurysm of the horizontal potion of the cavernous segment. The aneurysm max diameter was 7. 24mm and the neck diameter was 3. 35mm. Vessel tortuosity was moderate. It was reported that after the microcatheter was in place at the aneurysm location the pipeline flex stent was delivered. The microc atheter was retrieved to deploy the pipeline. More than 50% of the pipeline was deployed, over 15mm, but both the middle and distal sections failed to open even after waiting for more than 10 minutes. The pipeline was retrieved into the microcatheter and then deployed again, again more than 15mm, but still there was no sign of opening after waiting for more than 10 minutes. A third attempt was also made to retrieve and redeploy without success. The pipeline was not placed in a vessel bend. The pipeline was retrieved from the patient with a snare retrieval device and replaced to complete the procedure. The devices were prepared and used per the instructions for use (ifu). There was no harm or injury to the patient. Ancillary devices: marksman 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 Key10762615
MDR Text Key215024348
Report Number2029214-2020-01079
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
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-25
Device Catalogue NumberPED-500-25
Device Lot NumberB031113
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2020
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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