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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 LASER THERAPY PRODUCT

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY LASER THERAPY PRODUCT Back to Search Results
Model Number PED2-475-20
Device Problem Activation Failure (3270)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/22/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the first pipeline (4. 5 mm x 30 mm) experienced catheter kickback during deployment, and the device became stuck in the xt27 microcatheter. It was noted there was no friction during delivery, and the catheter tip was under stress due to the proximal curves which resulted in the tip moving and the kickback. The physician removed the catheter and pipeline, and a new pipeline (4. 75 mm x 20 mm) was used with a phenom 27 microcatheter. The pipeline was delivered and opened in the desired landing zone. However, the distal segment of the pipeline failed to open despite more than two resheathing attempts. The pipeline was not positioned in a bend, and upon opening more of the device, it was noticed the body of the pipeline opened normally. The pipeline and phenom microcatheter were removed from the patient. A third pipeline (5 mm x 20 mm) experienced the same event as the second pipeline: the dista l end failed to open. After resheathing multiple times without success, the physician removed this pipeline as well. A competitor's product was then used to complete the procedure with no reported issues. 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. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left c6 internal carotid artery with a max diameter of 30 mm and a >10 mm neck diameter. It was noted the patient's vessel tortuosity was moderate.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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 Key10604103
MDR Text Key209374522
Report Number2029214-2020-00983
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIT
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 12/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/05/2022
Device Model NumberPED2-475-20
Device Catalogue NumberPED2-475-20
Device Lot NumberA778533
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/14/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/06/2019
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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