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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-375-18
Device Problems Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problems Aneurysm (1708); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
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 the pipeline failed to open distally and became stuck in the marksman catheter hub, which was later found to be accordioned. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the right ophthalmic artery segment. The max diameter was 12mm, and the neck diameter was 7mm. The patient's vessel tortuosity was moderate. The landing zone was 3. 36mm distal and 3. 68mm proximal. It was reported that after the device was implanted the tip did not open well. Repeated opening caused the microcatheter to rub against the pipeline protective cuff, which could not be separated. The pipeline became stuck at the catheter hub during deployment. A continuous flush had been administered. The physician had released the load/slack in the system, but this did not resolve the issue. It was noted that the proximal segment of the catheter had accordioned. There was no damage to the pushwire. The patient did not experience any symptoms or complications. The patient was noted to be alive with injury as angiographic results post procedure showed a cerebral vascular aneurysm. The devices were prepared according to the instructions for use (ifu). Ancillary devices include a 6f navien guide catheter, marksman microcatheter, and stryker. 014" 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 Key11753552
MDR Text Key248216399
Report Number2029214-2021-00515
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 08/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-375-18
Device Catalogue NumberPED-375-18
Device Lot NumberB142597
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/08/2021
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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