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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
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 malposition. 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 first case a (b)(6) boy presented after severe headache and was found to have a giant partially thrombosed fusiform aneurysm of the left middle cerebral artery. The m1 origin immediately proximal to the aneurysm was noted to be significantly stenotic. Two pipeline devices were placed in telescoping fashion from the distal ica to the superior m2 division, across the aneurysm and the area of parent vessel stenosis. Unfortunately, post placement angiography demonstrated critical stenosis of the more proximal device at the site of pre-existing stenosis. Insufflation of compliant and non-compliant balloons temporarily opened the device, but deflation and removal of the balloons resulted in reappearance of the flow-limiting stenosis. With support from a guide catheter within a long access sheath, a bms was successfully deployed to overcome the stenosis. The patient was discharged on the second postoperative day. Six month follow-up angiography demonstrated successful parent vessel reconstruction of the previously diseased left m1 artery with mild in-stent stenosis at the site of the bms. The patient's headaches were resolved.
 
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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 Key10999343
MDR Text Key221259810
Report Number2029214-2020-01290
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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