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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-400-20
Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/22/2020
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 pipeline delivery system became stuck during retraction and the pushwire was found to be broken at the hypotube proximal to the wire weld. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left paraopthalmic artery. The max diameter was 5 mm, and the neck diameter was 4 mm. The patient's vessel tortuosity was moderate. Dual antiplatelet treatment had been administered, and the pru level was 8. The landing zone was 3. 2 mm distal and 3. 8 mm proximal. The access vessel was radial and 3 mm in diameter. It was reported that the pipeline ptfe sleeves caught inside distal navien. They could not pull pipeline wire out through navien, and they had to cork pipeline wire and pull entire system out. Upon evaluation the pipeline wire separated from wire at proximal point of no return. The pushwire/capture coil was stuck during retraction. The pushwire was rotated during removal. There was no damage to the catheter, but the pushwire was broken and detached at the hypotube proximal to the wire weld. The broken segment was removed from the patient through the catheter. There were no issues with the actual pipeline deployment, no patient issues related to this event, and the case was otherwise uneventful. The event occurred while removing system from patient proximal to petrous ica. The stent had been deployed successfully, and the issue was contained within the navien catheter and removed from the patient successfully. The patient did not experience any injury or complications. The devices were prepared according to the instructions for use (ifu). Angiographic results post procedure showed no issues. Ancillary devices include a navien 058 guide catheter, phenom 27 microcatheter, and infinity 088 90cm sheath.
 
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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 Key11114405
MDR Text Key225063515
Report Number2029214-2021-00007
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 01/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-20
Device Catalogue NumberPED-400-20
Device Lot NumberA852545
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/22/2019
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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