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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-475-20
Device Problem Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that a construct was built using multiple pipelines, but one of the pipelines was bumped and disconnected from the other construct. There was no patient injury as a result of the event. In a follow-up procedure on october 9, the case was completed by implanting a 5x35 pipeline to connect the construct. The case went very well, and the patient was doing fine following the procedure. The physician also placed a pipeline in the left internal carotid artery to successfully treat an aneurysm. It was noted all devices had been prepared per the instructions for use (ifu). The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm of the cavernous internal carotid artery. It was noted the patient's vessel tortuosity was normal.
 
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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 Key10672079
MDR Text Key211130750
Report Number2029214-2020-01023
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 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-475-20
Device Catalogue NumberPED-475-20
Device Lot NumberA784347
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 Received10/26/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/16/2019
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: 10/13/2020 Patient Sequence Number: 1
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