• 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 PED2-450-20
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problems Ischemia (1942); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
Event Date 09/06/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information reporting that on (b)(6) 2021, a pipeline flex with shield (model: ped2-450-20, lot: b209283) was being implanted in attempts to treat 2 unruptured supraclinoid left internal carotid artery (ica) aneurysms. After the pipeline was delivered, there was some foreshortening resulting in incomplete neck coverage of the more distal aneurysm. There was no friction or difficulty during delivery or positioning. The tip of the catheter was not moved during deployment. The pipeline did not jump during deployment but missed the landing zone. A second, shorter pipeline flex with shield (model: ped2-450-12, lot: b208340) was then placed distally in the proximal m1 for full coverage. Both devices opened well with good apposition seen in final angio. The patient was prescript dual antiplatelet treatment (dapt) - aspirin and brillinta. 2 days after discharge, the patient began experiencing stroke symptoms and was readmitted on (b)(6) 2021. On (b)(6) 2021, the patient was admitted to intensive care (icu) and a thrombectomy was done. Occlusion recurred on (b)(6) 2021 and another thrombectomy was successfully performed.
 
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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12461506
MDR Text Key272884394
Report Number2029214-2021-01158
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-450-20
Device Catalogue NumberPED2-450-20
Device Lot NumberB209283
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 Received09/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/20/2021
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: 09/13/2021 Patient Sequence Number: 1
-
-