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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-325-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Visual Disturbances (2140)
Event Date 09/20/2018
Event Type  Injury  
Manufacturer Narrative
The pipeline flex will not be returned for evaluation as it implanted in the patient. Based on the reported information, there did not appear to have been any defect of the device during use. The event occurred in the patient post procedure and its cause was unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information through clinical study that the patient had binocular visual blur post procedure. No treatment was given, and the event outcome was unknown.
 
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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 Key10336034
MDR Text Key200772075
Report Number2029214-2020-00741
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
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 10/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-325-16
Device Catalogue NumberPED-325-16
Device Lot NumberA415959
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 Received10/02/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/28/2020 Patient Sequence Number: 1
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