MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 10128843
• MDR Text Key: 200988825
• Report Number: 2029214-2020-00525
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• 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 Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-REP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention