• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-400-25
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Headache (1880); Neurological Deficit/Dysfunction (1982)
Event Date 06/10/2016
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 the target aneurysm was found due to a cranial nerve disorder with the patient. The aneurysm was treated with a pipeline on (b)(6) 2016 with no problems or adverse events during the procedure. On (b)(6) 2016 it was reported the patient experienced mass effect worsening, headache, and ocular motility disorder of a serious severity. It was reported there was no causal relationship with the equipment or procedure. The inflammation was determined to be caused by rapid thrombus formation of the aneurysm. The patient recovered on (b)(6) 2016. Six months post-procedure it was noted there was no more mass effect and the corrected rankin scale rating was 0. Aspirin and clopidogrel treatment was stopped at the three year follow up on (b)(6) 2019. The patient was undergoing surgery for treatment of a saccular aneurysm of the right c3 cavernous sinus with a max diameter of 29. 4 mm and a 8. 2 mm neck diameter. It was noted the patient's blood flow was xxx and vessel tortuosity was xxx.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
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 Key10675904
MDR Text Key211251964
Report Number2029214-2020-01026
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.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 10/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/10/2018
Device Model NumberPED-400-25
Device Catalogue NumberPED-400-25
Device Lot NumberA158884
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 10/14/2020 Patient Sequence Number: 1
-
-