• 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 W/SHIELD TECHNOLOGY 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 W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-375-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Paralysis (1997); Dysphasia (2195); Obstruction/Occlusion (2422); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
Event Date 09/21/2021
Event Type  Injury  
Manufacturer Narrative
Healthcare provider information is not provided based on country privacy laws. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information reporting that a patient had a pipeline flex with shield implanted for treatment of an unruptured saccular aneurysm of the left ophthalmic artery c6 segment. The aneurysm max diameter was 6. 0mm and neck diameter was 2. 0mm. Post-operatively, vascular occlusion including perforating branches was noted related to a cerebral infarction. The patient experienced right side paralysis, aphasia, and neurological deterioration ("nerve dislodgement"). It was noted the only patient symptom prior to the procedure was headache and the patient received antiplatelet therapy.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key12722881
MDR Text Key282343787
Report Number2029214-2021-01365
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-375-16
Device Catalogue NumberPED2-375-16
Device Lot NumberB241885
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/29/2021
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: 10/29/2021 Patient Sequence Number: 1
-
-