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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 Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Therapeutic Response, Decreased (2271)
Event Date 07/07/2018
Event Type  Injury  
Manufacturer Narrative
Bhogal, p. , chudyk, j. , bleise, c. , lylyk, i. , perez, n. , henkes, h. , <(>&<)> lylyk, p. (2018). The use of flow diversion in vessels
=
2. 5 mm in diameter¿a single-center experience. World neurosurgery, 118. Doi:10. 1016/j. Wneu. 2018. 06. 245 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 article: 2029214-2018-00933, 2029214-2018-00934. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found reports of post-procedure complications after pipeline implantation. The purpose of this article was to review the use of flow diversion on vessels less than or equal to 2. 5mm in diameter. The authors retrospectively reviewed patient data and identified 29 patients (22 female, 7 male) with an average age of 56 years who underwent flow diversion treatment of aneurysms. The article notes the following outcomes of pipeline patients: - patient 3 ((b)(6) female) underwent placement of a pipeline 3x16 in the treatment of a saccular aneurysm in the left a1-a2. The patient experienced a frontal lobe hemorrhage. The patient did not require decompressive craniotomy and made a good recovery. - patient 5 ((b)(6) female) underwent placement of a pipeline 3x20 in the treatment of a fusiform aneurysm in the right p2-p3. Sometime post-procedure, the patient underwent retreatment in which additional flow diverters were placed in a telescoping manner. - patient 6 ((b)(6), female) underwent placement of a pipeline 3x16 in the treatment of a fusiform aneurysm in the left p2-p3. Sometime post-procedure, small infarction was seen on follow-up imaging; the patient made a good recovery and had an mrs of 0 at 90 days. In addition, the patient underwent retreatment sometime post-procedure in which additional flow diverters were placed in a telescoping manner. - patient 11 ((b)(6), female) underwent placement of two pipeline devices (3x18, 3. 25x18) in the treatment of a fusiform aneurysm in the right mca bifurcation. Sometime post-procedure, small infarction was seen on follow-up imaging; the patient made a good recovery and had an mrs of 0 at 90 days. In addition, the patient underwent retreatment sometime post-procedure in which additional flow diverters were placed in a telescoping manner.
 
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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 Key8061840
MDR Text Key126917413
Report Number2029214-2018-00934
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
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 Received10/18/2018
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: 11/12/2018 Patient Sequence Number: 1
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