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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Loss of Vision (2139); Stenosis (2263); Therapeutic Response, Decreased (2271)
Event Date 02/23/2018
Event Type  Injury  
Manufacturer Narrative
Dodier, p. , frischer, j. M. , wang, w. , auzinger, t. , mallouhi, a. , serles, w. ,. Bavinzski, g. (2018). Immediate flow disruption as a prognostic factor after flow diverter treatment: long-term experience with the pipeline embolization device. World neurosurgery. Doi:10. 1016/j. Wneu. 2018. 02. 096 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. Mdrs related to this patient: 2029214-2018-00320, 2029214-2018-00321, 2029214-2018-00322, 2029214-2018-00323. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found reports of patient complications after pipeline placement. The purpose of this article was to report the long-term results after pipeline embolization device (ped) implantation. The authors retrospectively reviewed 40 patients with 59 aneurysms who underwent placement of 54 peds. The patients' mean age was 52. 3 years; 34 of the patients were female. The article notes the following early procedure-related complications ( < 30 days post-procedure): - 1 ipsilateral hemorrhage resulting in poor clinical status (mrs 5) - 1 contralateral hemorrhage - 3 ophthalmoplegia or visual impairment: 2 transient and 1 pre-existing/persisting - 1 asymptomatic in-stent stenosis on follow up angiography. In addition, one patient underwent placement of two peds; later on, a neck remnant was observed and was consequently retreated.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key7449973
MDR Text Key106139012
Report Number2029214-2018-00322
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P100018.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 04/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2018
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 Received03/26/2018
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: 04/23/2018 Patient Sequence Number: 1
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