• 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 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 INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Vasoconstriction (2126); Stenosis (2263); Therapeutic Response, Decreased (2271); Thromboembolism (2654); Vascular Dissection (3160)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative

The pipeline devices have not been returned for evaluation; product analysis cannot be performed. The devices have not been returned; the reported events could not be confirmed. The causes of the events could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Harland ta, seinfeld j, white ac, kumpe da, roark cd, case de. Comparative analysis of unruptured cerebral aneurysm treatment outcomes and complications with the classic versus flex pipeline embolization devices and phenom versus marksman microcatheter delivery system: the role of microcatheter choice on complication rate. J vasc interv neurol. 2020;11(1):13¿18. Medtronic literature review found reports of patient complications after pipeline implantation. The purpose of this article was to evaluate the outcomes of aneurysms treatment with pipeline flex vs. Pipeline classic. The authors reviewed the results of 75 pipeline (ped) procedures: 35 ped classic and 40 ped flex. The following outcomes were noted: of the ped classic cohort: - 3 thrombosis - 2 intraprocedural hemorrhage - 3 dissection - 13 vasospasm - 4 intimal hyperplasia - 2 periprocedural ischemic stroke - 2 subarachnoid hemorrhage - 1 intraparenchymal hemorrhage - 2 retreatment.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE
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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9930405
MDR Text Key195547430
Report Number2029214-2020-00341
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 04/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received03/10/2020
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: 04/06/2020 Patient Sequence Number: 1
-
-