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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); Deafness (1801); Edema (1820); Ischemia (1942); Transient Ischemic Attack (2109); Dysphasia (2195); Quadriplegia (2449)
Event Date 06/19/2013
Event Type  Injury  
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 verte bral 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 3) a (b)(6) male underwent surgery to treat a giant fusiform aneurysm. The patient developed multiple symptomatic small infarcts and perimedullary edema with partial neurological recovery. - (case 6) a (b)(6) female underwent surgery to treat a giant multilobulated fusiform aneurysm. The patient experienced a tiny left medial medullary infarct that resulted in a right-sided medullary pain syndrome that was effectively managed with medications. - (case 10) a (b)(6) male underwent surgery to treat a giant multilobulated saccular aneurysm. The patient awoke from the procedure with immediate unilateral deafness presumably related to eighth nerve damage caused by perforator or labyrinthine artery ischemia (no ischemia detected on magnetic resonance imaging). - (case 9) a (b)(6) female underwent surgery to treat a giant saccular aneurysm. The patient had stopped both aspirin and clopidogrel prematurely and experienced a transient ischemic attack with expressive dysphasia (complete resolution within, 24 hours, no ischemia detected on magnetic resonance imaging) at 97 days after the procedure. The patient was reloaded with aspirin and remained well. - (case 1) a (b)(6) female underwent surgery to treat a giant saccular aneurysm; however, progressive mass effect with temporary worsening of symptoms (quadriparesis and complete ophthalmoplegia) occurred after discontinuation of heparin on day 2 with computed tomography angiography demonstrating nearly complete aneurysm thrombosis. After steroid bolus therapy (additional bolus of 4 mg plus ongoing 4 · 4 mg/d dexamethasone), the patient improved markedly within 3 days. At 18 months, computed tomography angiography demonstrated complete resolution of mass effect with complete neurological recovery.
 
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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 Key10128843
MDR Text Key200988825
Report Number2029214-2020-00525
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
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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