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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX LASER THERAPY PRODUCT Back to Search Results
Model Number PED-250-20
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2020
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 there was difficulty with placement of the pipeline as it moved proximally. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left internal carotid artery with a max d iameter of 5 mm and a 2. 5 mm neck diameter. It was noted the patient's vessel tortuosity was normal. It was reported that the procedure started normally following the instructions for use (ifu). The pipeline was advanced to the distal vasculature/landing zone without complication. The physician began deploying the pipeline, but the device migrated proximally. Multiple pipelines were not being used, there was no friction during delivery or positioning, the device did not jump, the pipeline was placed at least 3 mm past the neck of the aneurysm on each side, and the side branch(es) were not covered by the pipeline. It was also noted the tip of the catheter moved during deployment, and the pipeline missed the landing zone. Resheathing was attempted, but the delivery wire appeared to be floating freely within the pipeline device. The physician then tried to drag the pipeline more proximally, and the delivery wire still appeared to be floating freely within the pipeline device. It was decided to deploy the pipeline, which was done successfully and at the intended location. A second pipeline was used to build a construct for better proximal coverage. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Ancillary devices include a terumo pinnacle 6f, 6f navien 105cm, phenom27 150cm, synchro2 guidewire.
 
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Brand NamePIPELINE FLEX
Type of DeviceLASER THERAPY PRODUCT
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 Key10568093
MDR Text Key207981108
Report Number2029214-2020-00958
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,Followup
Report Date 10/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/04/2021
Device Model NumberPED-250-20
Device Catalogue NumberPED-250-20
Device Lot NumberA670594
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 Received10/13/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/05/2018
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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