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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-450-25
Device Problems Retraction Problem (1536); Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/05/2020
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 sleeves became stuck on the microcatheter during retrieval and scraped the pipeline into the aneurysm sac. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm with a max diameter of 11. 3mm and a 6. 7mm neck diameter. It was noted the patient's vessel tortuosity was severe. It was reported that the microcatheter was in place, the pipeline was deployed smoothly with no issues. After deployed, the distal segment of the pushwire could not be retrieved because the distal ptfe protective sheath was stuck with the tip of the microcatheter. Repeated attempts at retrieval failed, and the physician had to withdraw the system as a whole. When withdrawing, the protective sheath rubbed the tip of the pipeline which resulted in the pipeline scraped into the aneurysm sac. Another pipeline was selected and deployed and retrieved smoothly. 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. Post procedure angiographic results showed slow blood flow.

 
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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 Key10407523
MDR Text Key203159584
Report Number2029214-2020-00797
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberP100018.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
Report Date 09/23/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/14/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPED-450-25
Device Catalogue NumberPED-450-25
Device LOT NumberB002741
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 Received09/09/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/02/2020
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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