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 Hematoma (1884); Hemorrhage, Cerebral (1889); Hemorrhage, Subarachnoid (1893); Paralysis (1997); Paresis (1998); Therapeutic Effects, Unexpected (2099); Thrombosis (2100); Transient Ischemic Attack (2109); Loss of Vision (2139); Dysphasia (2195); Stenosis (2263); Thromboembolism (2654)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

I.Saatci, k.Yavuz, c.Ozer, s.Geyik, h.S.Cekirge.Treatment of intracranial aneurysms using the pipeline flow-diverter embolization device: a single-center experience with long-term follow- up results.American journal of neuroradiology 33 (2012).Doi: 10.3174/ajnr.A3246.Background and purpose: flow-diverting devices now offer a new treatment alternative for cerebral aneurysms.We present the results of a large single-center series of patients treated with the ped, including long-term follow-up.Materials and methods: between november 2008 and september 2011, sidewall aneurysms with a wide neck (greater than or equal to 4 mm) or unfavorable dome-neck ratio (greater than or equal to 1.5); large/giant, fusiform, dissecting, blisterlike, and recurrent sidewall aneurysms; aneurysms at difficult angles; and aneurysms in which a branch was originating directly from the sac were treated with the ped.Patients were premedicated with dual antiplatelet medications.Data, including demographics, aneurysm features, clinical presentation, complications, results, and follow-up information, for up to 2 years are presented.Results: two hundred fifty-one aneurysms in 191 patients were treated.Of these, 96 (38.3%) were large or giant (greater than or equal to 10 mm).In 34/251 (13.5%), peds were used for retreatment.Adjunctive coiling was performed in 11 aneurysms (2.1%).The mean number of devices per aneurysm was 1.3.One aneurysm ruptured in the fourth month posttreatment (0.5%), and symptomatic in-construct stenosis was detected in 1 patient (0.5%) treated with percutaneous transarterial angioplasty.Any event rate was 27/191 (14.1%), with a permanent morbidity of 1% and mortality of 0.5%.Control angiography was available in 182 (95.3%) patients with 239 (95.2%) aneurysms.In 121 aneurysms (48.2%), 1- to 2-year control angiography was available.The aneurysm occlusion rate was 91.2% in 6 months, increasing to 94.6%.Conclusions: use of the ped is safe, efficacious, and durable in cerebral aneurysm treatment, with low morbidity-mortality and high occlusion rates as confirmed with mid- to long-term control angiography.Reported events.Two patients developed ipsilateral remote intraparenchymal hematomas.The first patient¿s hematoma developed within the first 8 hours after treatment.This hematoma was attributed to overmedication.The patient was placed on subcutaneous low-molecular-weight heparin despite her very high response to clopidogrel (the verifynow level was 97%) because the artery was reconstructed by using 16 devices overlapping in a telescopic fashion and we were worried about thromboembolic complications due to metal overload.The patient did not have any permanent neurologic sequelae from this event and was discharged home after 1 week.Control angiography showed total obliteration of the aneurysm with the parent artery reconstruction.The second patient, a woman with a small distal anterior cerebral artery aneurysm, was noted to have a hematoma 4 weeks posttreatment.The patient was admitted to the hospital with a gcs score of 11, and a control angiography showed total occlusion of the aneurysm with a verifynow level at admission of 98%.Clopidogrel was discontinued, and a craniectomy was performed to relieve the increased intracranial pressure on day 5.Her initial right hemiplegia and dysphasia improved during her stay of 2 months in the hospital, and she was discharged to a rehabilitation center, being able to walk.She improved clinically after the rehabilitation, and in the fourth month, she had a modified rankin scale score of 3, with remaining mild dysphasia and mild paresis on the left but was able to walk independently and use the upper extremities.One patient had subarachnoid hemorrhage from the treated aneurysm, which happened within the fourth month after ped placement.The control cta at 3 months had shown significant decrease in the filling of the aneurysm sac, but the aneurysm was not completely obliterated and initially they had hemiparesis.The patient was admitted to another hospital with a gcs score of 13.Clopidogrel and aspirin were discontinued immediately on admission.The patient recovered well with no neurologic deficit and was transferred to our center.Following premedication, she was taken for retreatment where the diagnostic angiography showed some contrast filling at the neck region.Two additional peds were placed with no adverse events.The 6-month control angiography (according to the initial therapy) showed complete occlusion of the aneurysm.One patient had dysphasia 8 weeks postoperatively after the treatment of a left supraclinoid large ica aneurysm with 3 peds.Mr imaging showed an acute ischemic lesion in the broca area, and the patient was emergently taken for angiography where significant stenosis of the left ica at the edge of the ped and within the devices was noted.Balloon angioplasty was successful, and good antegrade flow was restored.This patient currently has undergone several control angiographies during 2 years and remains on clopidogrel with no symptoms.In two patients, stenosis was discovered in the control angiography but pta was performed because the stenosis was considered significant (>70%).4 patients had worsening of their mass effect associated with the aneurysm treatment; 3 had deteriorating vision loss, of whom 2 also had visual field defects.In 2 patients, the symptoms regressed to their preoperative degree in the follow-up and caused permanent additional morbidity in 1.The remaining patient had symptoms due to mass effect on the brain stem, aggravated after the treatment, but resolved in 4 weeks¿ time.Three patients experienced peri-operative thromboembolic event in relation to the ped.One of the patients had an ischemic attack in the postoperative 4 months after he discontinued clopidogrel without consulting his doctor.The patient was medicated with iv heparin, and clopidogrel was loaded again.The symptom of monoparesis resolved totally.The same patient woke up from the general anesthesia with monoparesis but immediately became asymptomatic after volume loading and raising the blood pressure.The other patients' symptoms resolved totally.One patient experienced deep vein thrombosis associated with the intervention.Three patient's experienced retroperitoneal hematoma associated with the intervention.

• 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: 10129379
• MDR Text Key: 200984627
• Report Number: 2029214-2020-00528
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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): Required Intervention