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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Stenosis (2263)
Event Date 10/26/2019
Event Type  Injury  
Manufacturer Narrative
See related regulatory reports 2029214-2020-01290 and 2029214-2020-01291. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Cherian, jacob, mahsa dabagh, visish m srinivasan, stephen chen, jeremiah johnson, ajay wakhloo, vipul gupta, j macho, amanda randles, and peter kan. 2020. ¿balloon-mounted stents for treatment of refractory flow diverting device wall malapposition. ¿  operative neurosurgery (hagerstown, md. ) 19 (1): 37¿42. Doi:10. 1093/ons/opz297. Medtronic received a literature article aiming to describe the use of balloon-mounted stents within flow diverters for correction of flow-limiting stenosis and device malapposition. After attempts to perform balloon angioplasty proved unsuccessful, bms deployment successfully opened the stenotic parent artery and improved fdd wall apposition in all 4 cases. In the third case a 57-yr-old woman was found incidentally to have a giant left cavernous ica aneurysm. A site of pre-existing stenosis was noted immediately proximal to the aneurysmal segment. A compliant balloon was used to angioplasty the site of stenosis resulting in mildly improved vessel caliber. A pipeline device was then deployed to span the petrous and cavernous ica segments inclusive of the fusiform aneurysm. Unfortunately, post-deployment angiography revealed critical fdd stenosis at the site of pre-existing stenosis. Angioplasty with a non-compliant coronary balloon was not durable. A bms was then deployed at the site of stenosis with successful opening of the fdd and parent vessel. Post-angiography demonstrated mild residual narrowing. The patient¿s post-procedure course was complicated by seizures and concerns for hyper-perfusion syndrome. These symptoms were managed with steroids, hyperosmolar therapy, and blood pressure control. The patient ultimately improved clinically and was successfully discharged on the fourth postoperative day. The patient was asymptomatic at 6 month and follow-up angiogram showed complete aneurysm obliteration with no residual stenosis.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10999346
MDR Text Key221464337
Report Number2029214-2020-01292
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 12/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
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 Received12/13/2020
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: 12/13/2020 Patient Sequence Number: 1
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