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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-425-14
Device Problems Positioning Failure (1158); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Event Description
Medtronic received information that one ped2 pipeline failed to open and two pipelines had movement during deployment and had difficult placement and positioning. The patient was being treated for an unruptured carotid siphon aneurysm. Vessel tortuosity was severe. The devices were prepared according to the instructions for use (ifu).   pipeline 4. 25x14 and 4. 5x14 were not deployed because the system kept falling down after the initial deployment. Multiple pipelines were not being used when the movement occurred. There was no friction or difficulty during delivery or positioning. The pipeline was not implanted at the intended location. No additional steps were taken. The pipelines missed the landing zone. The device did not jump during deployment. The pipeline was placed at least 3mm past the aneurysm neck on each side. The tip of the catheter moved during the deployment. The procedure was successful and stent was deployed, stagnation was observed during the angiogram (post procedure). No symptoms were reported.   ancillary devices: navien guide catheter, phenom27 lot ap21-053 microcatheter, phenom 27 lot ju21-035 microcatheter, sheath.
 
Manufacturer Narrative
Event related to report 2029214-2022-00426. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13796390
MDR Text Key287350861
Report Number2029214-2022-00427
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTC
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-425-14
Device Catalogue NumberPED2-425-14
Device Lot NumberB087392
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/05/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/16/2020
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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