• 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 EMBOLIZATION DEVICE 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 EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Hematoma (1884); Ischemia (1942); Occlusion (1984); Dysphasia (2195); Rupture (2208); Stenosis (2263); Therapeutic Response, Decreased (2271); Paraplegia (2448)
Event Date 10/06/2018
Event Type  Injury  
Manufacturer Narrative
The pipeline devices will not be returned for evaluation as they remain implanted in the patients. Based on the provided information, there does not appear to have been any defect of the devices during use. The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Oishi, h. , teranishi, k. , yatomi, k. , fujii, t. , yamamoto, m. , <(>&<)> arai, h. (2018). Flow diverter therapy using a pipeline embolization device for 100 unruptured large and giant internal carotid artery aneurysms in a single center in a japanese population. Neurologia medico-chirurgica, 58(11), 461¿467. Doi: 10. 2176/nmc. Oa. 2018-0148. Medtronic literature review found reports of patient complications after pipeline flex implantation. The purpose of this article was to review the results of intracranial aneurysms treated with flow diverters (pipeline. ) the authors reviewed the results of 94 patients. The patients' mean age was 63. 4 years; 90 were women. The article notes the following outcomes: - 1 patient experienced significant in-stent stenosis on follow-up imaging without neurological symptoms. The patient underwent per cutaneous balloon angioplasty to resolve the stenosis. - 3 patients experienced spontaneous parent artery occlusion: 2 were asymptomatic and 1 was symptomatic. - 1 patient experienced from very delayed (>2 years after the procedure) device occlusion with a major ischemic stroke associated with discontinuation of antiplatelet therapy. - 1 patient experienced a minor stroke immediately following the procedure. Diffusion weighted-imaging on the day of the procedure showed multiple high intensity signals (hiss) in the treated cerebral hemisphere because of distal embolisms and/or parent artery flow insufficient during the ped deployment. The patient¿s symptoms were transient, and the patient fully recovered within 30 days after the procedure. - 4 patients experienced hemorrhagic events: dccf due to rupture of a treated aneurysm (2) and remote intraparenchymalhemorrhage (2). - 2 patients experienced delayed aneurysm rupture and developed dural carotid-cavernous fistula. The patients underwent transvenous coil embolization successfully with preservation of the ica. - 1 patient developed a large ipsilateral frontal lobe hematoma on the day after the procedure. One of the causes was thought to be excessive platelet inhibition. The patient had hemiplegia and dysphasia, there was steady but gradual improvement during a 3-month stay in the hospital. The patient was transferred to the rehabilitation center being able to walk without a cane. 1 patient developed a small, asymptomatic intraparenchymal hematoma in the temporal lobe of the ped deployed side 4 days after the procedure. The 6-month follow-up angiography showed the pao without any neurological deficits.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key9235113
MDR Text Key174341232
Report Number2029214-2019-01070
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 foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received09/25/2019
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: 10/24/2019 Patient Sequence Number: 1
-
-