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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 Problems Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)
Patient Problems Blurred Vision (2137); Dizziness (2194); Stenosis (2263)
Event Date 04/15/2020
Event Type  Injury  
Event Description
Ting wang, seidu a. Richard, he jiao, junrao li, sen lin, changwei zhang, chaohua wang, xiaodong xie, chao you; medicine; 2021; 100:11; institutional experience of in-stent stenosis after pipeline flow diverter implantation a retrospective analysis of 6 isolated cases out of 118 patients; doi. Org/10. 1097/md. 0000000000025149 medtronic received information though a literature article that patient's treated pipeline stent (ped) had compilations.   the study was a retrospective analysis of patient's with in stent stenosis (iss) and its associated causes such as sharp change of the ped, distal wall malapposition, inconsistent compliance between parent artery as well as the ped occlusion due to intimal hyperplasia and vessel tortuosity. Patient's were treated for intracranial aneurysm form april 25, 2018 to april 24, 2019.  all patients were given 100mg of aspirin and 75mg of clopidogrel daily for at least 5 days prior to the procedures.  the peds were deployed via marksman microcatheters. In all, 6 cases were defined as iss by 2 independent neurointerventionalists with consistency out of 118 aneurysm patients treated with peds.  the patients were made up of 2 males and 4 females with a mean age of 42. Only one of the patients was a child while the rest where adults. Three of the patients were asymptomatic according to our analysis while 2 presented with dizziness and 1 with blurring of vision. Aneurysms where located in c4 segment in 2 patients and c6 in 3 patients. Only 1 patient had an aneurysm in the b-v4 segment of the vertebral artery. Endovascular treatments were successful in all patients without procedure-related complications. However, in one case, the first implanted ped dropped into the aneurysmal sacs so 2 more peds with larger sizes were implanted again.  ped implantation with coiling was done in 1 patient while the remaining 5 patients received only peds implantations. Associated wall malapposition was observed in 2  patients. In both patients, the wall malappositions occurred in the distal segments of the internal carotid arteries (ica)s. Three patients had raymond-roy occlusion classification (roc) 1 aneurysmal occlusion while the remaining 3 had roc3.  one case was rated as severe iss on 6-month follow-up. The patient¿s degree of iss deteriorated on 12-month follow-up visit without any ischemic events and no remedial measures were taken because of patients¿ refusal of further treatment.  moderate iss was identified in 3 cases in the first follow-up. Of which 1 case aggravated into severe iss accompanied by obvious flow restriction on the second follow-up imaging. Balloon angioplasty and neuroform ez 4. 5*20 were used to retreat this patient and the iss resolved. The patient¿s iss was dramatically improved on 12months follow-up visits.  two patients had mild iss which did not aggravate on all follow-up visits and thus these patients were not retreated. Nevertheless, their iss did not resolve too.  shape change was responsible for 2 cases, while distal malapposition of ped was considered as the cause in 2 cases.  inconsistent compliance between parent arteries and stents werereasons for iss in the remaining 2 cases.  furthermore, pled stenosis due to intimal hyperplasia and vessel tortuosity was observed in one case.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13501619
MDR Text Key286496278
Report Number2029214-2022-00191
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
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
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/08/2020
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: 02/09/2022 Patient Sequence Number: 1
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