• 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
Model Number NV UNK PIPELINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Thrombus (2101); Transient Ischemic Attack (2109); Perforation of Vessels (2135); Thromboembolism (2654); Vascular Dissection (3160)
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Felipe padovani trivelato, eduardowajnberg, marco túlio salles rezende, alexandre cordeiro ulhôa, ronie leo piske, thiago giansante abud, luís henrique de castro-afonso, carlos gustavo coutinho abath, guilherme seizemnakiri, joão francisco santoro araújo, josé laércio júnior silva, renato tavares tosello, josé ricardo vanzin, luciano bambini manzato, carlos eduardo baccin, bruno anderson araújo damota, daniel giansante abud. Safety and effectiveness of the pipeline flex embolization device with shield technology for the treatment of intracranial aneurysms: midterm results from a multicenter study. Doi:10. 1093/neuros/nyz356. Medtronic literature review found a report of complications after use of pipeline. The purpose of the article was to evaluate the outcomes of patients harboring aneurysms treated with the ped shield. Among 151 patients, 120 (79. 5%) were women, and their mean age was 52. 7 yr. - at primary safety endpoint, 9 patients experienced the following complications: 3 minor strokes, 2 disabling ischemic strokes, 1 tia, 1 hemorrhage, 1 increase of mass effect, and 1 retinal ischemia. Periprocedural complications included 4 dissections of cervical vessels, 3 thromboembolic complications, and 2 vessel perforations. Periprocedural in-stent thrombus was identified in 2 patients that were included in the ischemic complications.

 
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 Key10017242
MDR Text Key194535810
Report Number2029214-2020-00420
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberP100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 05/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device LOT NumberNOT-RPT
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 Received04/29/2020
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: 05/01/2020 Patient Sequence Number: 1
-
-