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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Paresis (1998); Vasoconstriction (2126); Rupture (2208); Stenosis (2263); Obstruction/Occlusion (2422); Cognitive Changes (2551); Thromboembolism (2654); Vascular Dissection (3160); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
Event Date 06/16/2021
Event Type  Injury  
Event Description
Gündogmus, c.A., sabet, s., baltacioglu, n.A., türeli, d., bayri, y., <(>&<)>amp; baltacioglu, f.(2021).Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.Interventional neuroradiology, 159101992110307.Https://doi.Org/10.1177/15910199211030780 summary: internal carotid artery (ica) aneurysms constitute 30% of all intracranial aneurysms and are ever more frequently diagnosed thanks to the ubiquitous use of magnetic resonance imaging.1 due to these inherently large and wide-necked aneurysms, endovascular treatment of ica aneurysms is exceptionally troublesome and has high recurrence rates even with stent-assisted coil embolization techniques.Identified events: 1.Two patients experienced severe in-stent stenoses.2.One patient was treated with fred and coils 20 days after presenting a bleeding posttraumatic dissecting aneurysm.He was discharged without sequelae.3.One patient had a thromboembolism.4.In-stent thrombus developed in one patient during the procedure was managed by intraarterial infusion of 3 mg tirofiban.The patient woke up from anesthesia without deficit, and post-intervention dwi showed no infarcts.5.One patient was reevaluated due to loss of consciousness on the fifth day post-intervention.Emergent dwi showed ipsilateral watershed infarcts, and dsa revealed total occlusion of device lumen, which could not be endovascularly reopened.The patient was managed conservatively and discharged 20 days later with moderate disability, i.E., three points on the modified rankin scale (mrs).On the sixth month control, the patient was symptom-free (mrs =0).6.One patient with bilateral ica aneurysms who received flow diverters bilaterally in the same session experienced transient right hemiparesis on the fourth day post-procedure.Emergent dsa revealed small patches of partially occluding thrombi in both devices.Low molecular weight heparin (lmwh) was started for a month in addition to clopidogrel and aspirin.The patient was asymptomatic on the second day after initiation of lmwh, and control dsa on the 15th day showed that thrombi resolved completely.7.One patient woke up from anesthesia with facial palsy, whose immediate catheter angiogram revealed diffuse thrombus within the de vice, causing near-total occlusion.The patient was treated with aspiration thrombectomy and intra-arterial infusion of 2 mg tirofiban, followed by a solitaire ab stent (medtronic neurovascular, irvine, ca).8.One patient with early thromboembolic complications presented with contralateral hemiparesis on the third day poststenting.Dsa revealed in-stent thrombus and stagnant antegrade flow treated by intra-arterial infusion of 1 mg tirofiban.The patient was then given 2 mg tirofiban intravenously and infusion for 48 h.She was discharged with mrs =1.On the sixth month control dsa, the device was severely stenosed, and ipsilateral middle cerebral artery (mca) flow was being reconstituted through pial collaterals of aca.Her mrs was 0 then and remained unchanged later, even though the stent lumen was totally occluded on the 24th month dsa.Finally, a thromboembolic event occurred in the patient treated with ped while doing diagnostic angiography to the contralateral left ica.The patient was discharged with no deficits.9.One patient treated with flow diversion only, with ped, was readmitted with spontaneous rupture on the 16th day post-procedure.E mergent angiography showed no active filling of the aneurysmal sac.Nevertheless, two additional peds were deployed into the lumen of the current device in a telescopic fashion.Re-bleeding did not occur.However, severe cerebral vasospasm leading to brain stem in farction resulted in severe disability (mrs=5).10.Only one case was complicated with a systemic hemorrhage during follow-up; one ped patient, receiving prasugrel, had gastrointestinal bleeding on the 50th day post-treatment, which prompted cessation of antiaggregant temporarily.The patient did not have ischemic events afterward.11.One patient treated with bilateral ped developed severe stenosis at the middle part of the right device and the distal end of the left device lumens.The patient was asymptomatic and remained so.The degree of stenoses did not show any interval change.Additional event information: pipeline embolization device (ped; ev3 neurovascular, irvine, ca).Fifty-four patients (39.1%) were diagnosed incidentally, whereas 49 patients (35.5%) presented with headache, 11 patients (8%) with subarachnoid hemorrhage due to ruptured index aneurysm, one patient (0.7%) with subarachnoid hemorrhage originating from a different aneurysm, 14 patients (10.1%) with cranial nerve dysfunction, and nine patients (6.5%) with neurologic deficits such as hemiparesis and paresthesia.In 19 patients, one flow diverter was used to treat two aneurysms; in two patients, one device was used to treat three aneurysms; and one patient had six adjacent aneurysms covered using a single device.In addition, one patient who was initially treated with ped required two additional peds to be deployed telescopically due to early spontaneous rupture of the treated aneurysm.In another patient, treatment of a bleeding blister aneurysm called for the deployment of three ped devices telescopically during the same session.Additional coiling was used in treatment of 17 patients.
 
Manufacturer Narrative
Gündogmus, c.A., sabet, s., baltacioglu, n.A., türeli, d., bayri, y., <(>&<)>amp; baltacioglu, f.(2021).Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.Interventional neuroradiology, 159101992110307.Https://doi.Org/10.1177/15910199211030780 a.2.This value is the average age of the patients reported in the article as specific patients could not be identified.A.3.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.B.3.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not p rovided in the published literature.B.5.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Associated regulatory reports: 2029214-2022-00304, 2029214-2022-00305 and 2029214-2022-00306.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PIPELINE
Type of Device
INTRACRANIAL 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 Key13602803
MDR Text Key286151050
Report Number2029214-2022-00307
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/28/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Life Threatening; Hospitalization; Disability;
Patient Age52 YR
Patient SexFemale
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