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 Fistula (1862); Hematoma (1884); Ischemia (1942); Occlusion (1984); Dysphasia (2195); Rupture (2208); Stenosis (2263); Therapeutic Response, Decreased (2271); Paraplegia (2448)

Event Date 10/06/2018

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

Event Description

Oishi, h., teranishi, k., yatomi, k., fujii, t., yamamoto, m., <(>&<)> arai, h.(2018).Flow diverter therapy using a pipeline embolization device for 100 unruptured large and giant internal carotid artery aneurysms in a single center in a japanese population.Neurologia medico-chirurgica, 58(11), 461¿467.Doi: 10.2176/nmc.Oa.2018-0148.Medtronic literature review found reports of patient complications after pipeline flex implantation.The purpose of this article was to review the results of intracranial aneurysms treated with flow diverters (pipeline.) the authors reviewed the results of 94 patients.The patients' mean age was 63.4 years; 90 were women.The article notes the following outcomes: - 1 patient experienced significant in-stent stenosis on follow-up imaging without neurological symptoms.The patient underwent per cutaneous balloon angioplasty to resolve the stenosis.- 3 patients experienced spontaneous parent artery occlusion: 2 were asymptomatic and 1 was symptomatic.- 1 patient experienced from very delayed (>2 years after the procedure) device occlusion with a major ischemic stroke associated with discontinuation of antiplatelet therapy.- 1 patient experienced a minor stroke immediately following the procedure.Diffusion weighted-imaging on the day of the procedure showed multiple high intensity signals (hiss) in the treated cerebral hemisphere because of distal embolisms and/or parent artery flow insufficient during the ped deployment.The patient¿s symptoms were transient, and the patient fully recovered within 30 days after the procedure.- 4 patients experienced hemorrhagic events: dccf due to rupture of a treated aneurysm (2) and remote intraparenchymalhemorrhage (2).- 2 patients experienced delayed aneurysm rupture and developed dural carotid-cavernous fistula.The patients underwent transvenous coil embolization successfully with preservation of the ica.- 1 patient developed a large ipsilateral frontal lobe hematoma on the day after the procedure.One of the causes was thought to be excessive platelet inhibition.The patient had hemiplegia and dysphasia, there was steady but gradual improvement during a 3-month stay in the hospital.The patient was transferred to the rehabilitation center being able to walk without a cane.1 patient developed a small, asymptomatic intraparenchymal hematoma in the temporal lobe of the ped deployed side 4 days after the procedure.The 6-month follow-up angiography showed the pao without any neurological deficits.

• 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: 9235113
• MDR Text Key: 174341232
• Report Number: 2029214-2019-01070
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 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