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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-500-35
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
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 two pipeline devices failed to open in the middle and proximal sections. The patient was undergoing treatment for an amorphous, direct carotid-cavernous fistula in the left ica due to blunt force trauma. The patient's vessel tortuosity was severe. The landing zone was 7mm distal and 10mm proximal. The access vessel was the ica, which was 5mm in diameter.  dual antiplatelet treatment was administered. It was reported that pipeline had trouble coming through the acute turn of the anterior genu. They continued trying to deploy, hoping that with wagging, loading, and centering the device might start to open more. At one point it looked like it was opening, but was ribboning/flattening too. The pipeline was not positioned in a bend when it failed to open, and more than 50% had been deployed at the time. The physician resheathed the pipeline two or less times, and no additional steps were taken to open the device. The physician replaced the pipeline, but to the same thing happened with the new device. The physician removed this pipeline and tried with two stryker evolve devices, but similar deployment issues occurred.  they decided to complete deployment and balloon angioplasty. Angiographically, they were able to accomplish their goal. There was nothing visibly wrong or issues alleged with the microcatheter.  the patient did not experience any injury or complications. The devices were prepared and flushed according to the instructions for use (ifu). Ancillary devices include a cook 6fr shuttle sheath, navien 058 guide catheter, phenom 27 microcatheter, and synchro 2 guidewire.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12036212
MDR Text Key263440736
Report Number2029214-2021-00754
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 09/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-35
Device Catalogue NumberPED-500-35
Device Lot NumberB149223
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2021
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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