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

Model Number PED-475-25

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Neuropathy (1983); Therapeutic Response, Decreased (2271)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received the following report through literature review of ¿delayed posttreatment residual flow into aneurysm after flow diverter placement¿.A (b)(6) woman presented with a 28-month history of diplopia.Neuro-ophthalmologic tests revealed right oculomotor nerve palsy.Dsa revealed a large intracranial aneurysm measuring 23.0 _ 18.1 mm in the cavernous segment of the right internal carotid artery (ica).Seven days before the operation, the patient was started on oral doses of 100 mg aspirin and 75 mg clopidogrel per day.Aspirin reaction unit was 468 seconds, and p2y12 reaction units was 167 seconds, demonstrating the absence of any aspirin or clopidogrel resistance.Coaxial endovascular navigation under general anesthesia.A 7-french guiding sheath (shuttle sheath) was placed in the proximal cervical segment of the ica, and a 6-french navien was placed in the proximal intracranial segment of the ica.A 0.027 marksman was place with the aid of 0.014 chikai.A ped 4.75 _ 25 was delivered.The delivery microcatheter was then moved over the delivery wire to the distal edge of the ped, and the delivery wire was exchanged for a 0.010-inch outer diameter, 300-cm-x-celerator.The delivery microcatheter was exchanged for a hyperform 7_7mm, to perform balloon angioplasty to expand the ped and fix the stent along the arterial wall.Post procedure, dsa demonstrated flow stagnation inside the aneurysm dome.The postoperative course was uneventful, and the patient was discharged 9 days post procedure without new neurologic deficits.A 6-month follow-up dsa demonstrated delayed post-treatment residual flow into the aneurysm sac.No stent migration was observed.Although she was scheduled for additional fd placement because of concern for aneurysmal rupture, the operation was not conducted due to an interim motor vehicle accident.Oral treatment with aspirin (100 mg/day) and clopidogrel (75 mg/day) were continued during her recovery.A dsa conducted 12 months post fd treatment showed that the aneurysm had completely thrombosed.Right oculomotor nerve palsy had partially resolved.This case showed 2 key findings.First, dsa 6 months post procedure demonstrated delayed post-treatment residual flow into the aneurysm that was not observed following the initial procedure.Second, there was complete thrombosis of the aneurysm12 months after the fd treatment, despite the delayed posttreatment residual flow observed 6 months earlier.Follow-up dsa 7 days post procedure revealed partial thrombosis of the aneurysm with new post-treatment residual flow into the dome.This was accompanied by worsening of her cranial neuropathy, necessitating additional fd treatment.The present case provides additional evidence that post-treatment residual flow into an aneurysm can be observed not only immediately following fd placement but also after a period of days to months.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 8085521
• MDR Text Key: 129300920
• Report Number: 2029214-2018-00956
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PED-475-25
• Device Catalogue Number: PED-475-25
• Device Lot Number: NOT-REP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/31/2018
• 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