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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-500-12
Device Problem Activation Failure (3270)
Patient Problem Vasoconstriction (2126)
Event Date 04/29/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the two pipeline devices failed to open. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the paraophthalmic section of the right ica. The max diameter was 4. 18mm, and the neck diameter was 4. 28mm. The patient's vessel tortuosity was minimal. The landing zone was 4. 18mm distal and 4. 87mm proximal.  dual antiplatelet treatment was administered, and the pru level was 60. It was reported that the doctor attempted to deploy the (b)(4) as per the instructions for use (ifu), but it did not open. The distal portion slightly opened but was severely flat around the genu. The physician attempted to resheath and center the device, and had the navien catheter in the vertical petrous segment. After several attempts, the doctor pulled out the device along with the  marksman catheter. The doctor replaced the marksman and downsized the pipeline to a (b)(4). They attempted to open in the middle cerebral artery segment (mca), but the pipeline did not open distally or "cigared" where the middle portion would open. The physician pushed the wire more than 50% with both devices when they failed to open. After noticing spasm in the mca segment during an angiogram, the doctor decided to not risk further potential harm. They plan on attempting flow diversion with another flow diverter. It was noted that the proximal, middle, and distal portions of both pipelines failed to open. The middle part of the pipeline had been placed in a bend, and the physician had resheathed them more than 2 times. The doctor had attempted to reposition the devices in a straight segment, but they still failed to open. Both devices were removed from the patient.  angiographic results post procedure were said to be poor and showed that vasospasm occurred.  the patient outcome was alive with no injury. The devices were prepared according to the ifu. Ancillary devices include a ballast 088 long sheath, navien. 058 guide catheter, marksman microcatheter, and synchro standard 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 Key11780524
MDR Text Key249264639
Report Number2029214-2021-00543
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 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-12
Device Catalogue NumberPED-500-12
Device Lot NumberB158206
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/05/2021 Patient Sequence Number: 1
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