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

Model Number NV UNK FLEX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Transient Ischemic Attack (2109); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Trivelato, f.P., wajnberg, e., rezende, m.T.S., ulhoa, a.C., piske, r.L., abud, t.G., castro-afonso, l.H.De, abath, c.G.C., nakiri, g.S., araujo, j.F.S., silva, j.L.J., tosello, r.T., vanzin, j.R., manzato, l.B., baccin, c.E., mota, b.A.A.Da, & abud, d.G.(2020).Safety and effectiveness of the pipeline flex embolization device with shield technology for the treatment of intracranial aneurysms: midterm results from a multicenter study.Neurosurgery, 87(1), 104-111.Medtronic received a literature article aiming to evaluate the outcomes of patients harboring aneurysms treated with the pipeline shield device.151 patients with 182 aneurysms were enrolled between november 2017 and december 2018.The mean aneurysm size was 7.0 mm; 27 aneurysms were large, and 7 were giant.Most aneurysms involved the paraophthalmic segment of the internal carotid artery, followed by the cavernous segment.One-hundred seventy aneurysms were located in anterior circulation.There were 169 saccular aneurysms.A branch arising from the sac was observed in 29 aneurysms.The study involved a majority female participants of an average age 53 years.In 141 of 151 patients, the primary endpoint was reached.The overall rate of periprocedural complications was 7.3%.Of the aneurysms, 79.7% met the study's secondary endpoint of complete occlusion at 6 month follow up and 85.3% at 12 month follow up.In the study 9 patients experienced 3 minor strokes, 2 disabling ischemic strokes, 1 transient ischemic attack, 1 hemorrhage, 1 increase of mass effect, and 1 retinal ischemia were observed at follow-up.Four dissections of cervical vessels, 3 thromboembolic complications, and 2 vessel perforations, and 2 cases of in stent thrombosis were also observed.At the 6-mo follow-up, angiography revealed 2 cases of parent vessel occlusion and 3 cases of in-stent stenosis.No symptoms related to the stenosis/occlusion of the parent vessel were observed.All patients harboring ruptured aneurysms had an uneventful recovery.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 11016763
• MDR Text Key: 225566465
• Report Number: 2029214-2020-01309
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK FLEX
• Device Catalogue Number: NV UNK FLEX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• 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
• Patient Age: 53 YR