MAUDE Adverse Event Report: MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR PHENOM; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-FG

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

Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Rupture (2208); Thrombosis/Thrombus (4440)

Event Date 12/12/2016

Event Type  Injury  

Event Description

Piotin m, fahed r, redjem h, smajda s, desilles jp, escalard s, maïer b, hebert s, delvoye f, mazighi m , blanc r.The artisse intrasaccular device for intracranial aneurysm treatment: short-term, mid-term and longterm clinical and angiographic results.Journal of neurointerventional surgery.2021, 0:1-5.Doi: 10.1136/neurintsurg-2021-017806.The purpose of this study was to determine the clinical and angiographic outcomes of patients treated with the new artisse intrasaccular device (isd).Nine subjects with nine unruptured bifurcation aneurysms were enrolled.Of the 9 patients, the average age was 59 years, all 9 were female.Mean aneurysm size was 7.2±1.2 mm (range 5.5¿9.7 mm).An adequate aneurysm occlusion (defined as a complete occlusion or a neck remnant) was achieved in 6/9 patients (66.7%) at 6 months and 4/7 patients (57.1%) at 36 months follow-up.Two of the nine subjects experienced a major stroke (22.2%) one case of bifurcation aneurysm required the emergency bail-out deployment of two stents in y-configuration due to acute parent vessel occlusion immediately after deployment of the artisse isd.The patient received a 20 mg bolus of abciximab followed by continuous infusion.At postoperative day 1, abciximab was discontinued and the patient was prescribed dual antiplatelet therapy for 3 months (aspirin 250 mg and ticagrelor 180 mg daily), then aspirin 250 mg daily for a further 3 months.The patient was completely asymptomatic from that complication (mrs=0).Another patient developed an acute ischemic stroke at postoperative day 1 because of a parent vessel occlusion and was immediately brought to the angiographic suite for recanalization which was unsuccessful.The patient had a major stroke with permanent disability (mrs=3).One subject underwent endovascular treatment of a second untreated aneurysm with coiling; the procedure was complicated with aneurysm perforation and subsequent intraventricular hemorrhage with neurological sequelae (mrs=3).No patient died during follow-up.   the article does not state any technical issues during use of the phenom21.   the following intra- or post-procedural outcomes were noted:  1.Acute parent vessel occlusion  2.Acute ischemic stroke  3.Major stroke with permanent disability (mrs=3).  4.Aneurysm perforation  5.Intraventricular hemorrhage with neurological sequelae (mrs=3).

Manufacturer Narrative

Piotin m, fahed r, redjem h, smajda s, desilles jp, escalard s, maïer b, hebert s, delvoye f, mazighi m , blanc r.The artisse intrasaccular device for intracranial aneurysm treatment: short-term, mid-term and longterm clinical and angiographic results.Journal of neurointerventional surgery.2021, 0:1-5.Doi: 10.1136/neurintsurg-2021-017806.  age: 59 years is the average age of the patients who participated in the study.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PHENOM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR; 627 national ave; mountain view CA 94043
• Manufacturer (Section G): MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR; 627 national ave; mountain view CA 94043
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15174839
• MDR Text Key: 297333093
• Report Number: 2029214-2022-01305
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-FG
• Device Catalogue Number: UNK-NV-FG
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2022
• Initial Date FDA Received: 08/05/2022
• 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; Disability
• Patient Age: 59 YR
• Patient Sex: Female