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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 Infarction, Cerebral (1771); Death (1802); Edema (1820); Headache (1880); Hemorrhage/Bleeding (1888); Thrombosis (2100); Blurred Vision (2137); Dizziness (2194); Dysphasia (2195); Quadriplegia (2449); Ambulation Difficulties (2544); Lethargy (2560)
Event Date 06/19/2013
Event Type  Death  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

Stephan meckel, william mcauliffe, david fiorella, christian a. Taschner, constantine phatouros, timothy john phillips, paul vasak, martin schumacher, joachim klisch. Endovascular treatment of complex aneurysms at the vertebrobasilar junction with flow-diverting stents: initial experience. Neurosurger 73 (2013). Doi: 10. 1227/01. Neu. 0000431472. 71913. 07. Background: large or giant complex vertebrobasilar junction aneurysms have a dismal natural history and are often challenging to treat with standard endovascular or neurosurgical techniques. Objective: to report initial experience with endovascular treatment of these aneurysms using flow-diverting stents (fds). Methods: ten patients with fds treatment of complex vertebrobasilar junction aneurysms were collected from 4 large cerebrovascular centers. Clinical/angiographic presentation and outcome were retrospectively analyzed. Results: of 10 aneurysms, 7 presented with brainstem compression, 2 with ischemia, and 1 with subarachnoid hemorrhage, and 3 were recurrent after stent-assisted treatments. Eight were giant. Morphology was fusiform in 5, fusiform dissecting in 1, and multilobulated saccular in 4. Six were partially thrombosed. In addition to fds (mean number of devices, 3. 9; range, 1-9), contralateral vertebral artery sacrifice and adjunctive coiling were performed in 9 and 5 of the 10 patients, respectively. At follow-up, 5 of 10 were completely occluded, 4 showed minimal residual filling, and 1 was retreated with an additional fds. Postinterventionally, worsening mass effect and ischemic complications were seen in 2 and 4 of 10, respectively. Clinical outcome was good in 6 (modified rankin scale score, 0-2). Four fatalities were related to sequelae of subarachnoid hemorrhage, late fds thrombosis, progressive mass effect, and delayed intracranial hemorrhage. Conclusion: fds may be used to treat complex vertebrobasilar junction aneurysms with overall good angiographic outcome. A combined reconstructive/deconstructive approach appears useful to avoid endoleaks. Fds strategies, like other endovascular and neurosurgical approaches to these lesions, are associated with significant risk and therefore should be reserved for those cases in which alternative approaches either are deemed unsafe or are likely to be ineffective. Reported events. - (case 7) a (b)(6) year old male underwent surgery to treat a giant fusiform aneurysm who began to deteriorate clinically with progressive diplopia, gait instability, headache, and dizziness 5 months after the uncomplicated fds procedure and despite progressive aneurysm thrombosis. Magnetic resonance demonstrated slight enlargement of the aneurysm-thrombus mass with progression of associated brainstem edema. The patient was treated with intravenous dexamethasone. Because residual filling along the fds construct was seen, an additional ped was placed over the entry remnant. However, the patient continued to demonstrate gradual neurological deterioration with progressive quadriparesis, dysphagia, and lethargy and ultimately died 7 months after the original treatment. - (case 5) a (b)(6) year old male experienced a delayed in-stent thrombosis that occurred in 1 giant fusiform aneurysm treated with 9 overlapping peds 11 months after the procedure. Two weeks earlier, control digital subtraction angiography had demonstrated a largely thrombosed aneurysm with minimal residual inflow, and clopidogrel had been discontinued. Despite successful intravenous (eptifibatide), intra-arterial (recombinant tissue-type plasminogen activator) thrombolysis, mechanical thrombectomy, and surgical posterior fossa decompression, the patient ultimately died of large posterior circulation infarcts. - (case 8) a (b)(6) year old male underwent surgery to treat a giant fusiform aneurysm. The patient had multiple vascular risk factors and died due to delayed thalamic hemorrhage occurring 38 days after treatment.

 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key10128794
MDR Text Key194336896
Report Number2029214-2020-00524
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeGM
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 06/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/08/2020
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 NumberNOT-REP
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 Received05/27/2020
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: 06/08/2020 Patient Sequence Number: 1
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