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

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

Patient Problems Hemorrhage, Subarachnoid (1893); Ischemia (1942); Occlusion (1984); Thrombosis (2100); Therapeutic Response, Decreased (2271)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

The pipeline devices will not be returned for evaluation as they remain implanted in the patients.Based on the provided information, there does not appear to have been any defect of the devices during use.The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information.Mdrs related to this article: 2029214-2019-01071 2029214-2019-01072.If information is provided in the future, a supplemental report will be issued.

Event Description

Primiani, c.T., ren, z., kan, p., hanel, r., pereira, v.M., lui, w.M., ¿ mokin, m.(2019).A2, m2, p2 aneurysms and beyond: results of treatment with pipeline embolization device in 65 patients.Journal of neurointerventional surgery, 11(9), 903¿907.Doi: 10.11 36/neurintsurg-2018-014631.Medtronic literature review found reports of patient complications after pipeline placement.The purpose of this article was to describe the results of pipeline treatment of distal intracranial aneurysms.The authors reviewed the results of 65 patients with distal aneurysms treated with pipeline.Of the 65 patients, the mean age was 54.7 years; 42 of the patients were female.The article notes the following events: - four patients underwent retreatment - one patient presented with fusiform, m2 aneurysm with downstream ischemic stroke.The patient underwent placement of a pipeline device, which resulted in slow filling of a side branch.The slow filing resolved after administration of iib/iiia inhibitor.The patient showed extension of stroke on follow-up imaging.- one patient underwent pipeline placement in the treatment of a saccular, p2 aneurysm.The patient developed subarachnoid hemorrhage the same day post-procedure.The patient require centriculoperitoneal shunt.Patient's mrs was 1 at 3 months.- one patient underwent pipeine placement in the treatment of a fusiform, m2 aneurysm.The patient developed intraprocedural in-stent thrombosis, which resolved after administration of iib/iiia inhibitor.Patient's mrs was 0 at 3 months.-one patient underwent pipeline placement in the treatment of a ruptured, p2 aneurysm.The patient developed intraprocedural in-stent thrombosis, which resolved after administration of iib/iiia inhibitor and angioplasty.The patient deteriorated clinically two days post-procedure of suspected recurrent in-stent thrombosis.The patient had multiple strokes on follow-up mri.Mrs was 4 at 3 months.

• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9235913
• MDR Text Key: 174341825
• Report Number: 2029214-2019-01072
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2019
• 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