MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number PED-300-14

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thrombus (2101)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received report that the patient experienced sensory motor deficit on the left side.Arteriography showed platelet aggregate at the upper side of the stent.The treating site reported this event to be related to device and study procedure.This event did require medical intervention and prolonged hospitalization.The intervention consisted of percutaneous intervention medication.However, the symptoms did not last more than 24 hours.Post the uneventful pipeline deployment, there significant stasis and class 3 raymond roy.The device was reported to have been used to treat two aneurysms.Wall apposition was achieved.# 1: the aneurysm is in the right, middle cerebral artery, bifurcation branch.It was saccular in shape.The max diameter was 2mm, dome height was 3mm, width of 2mm, and the neck was 3mm.Post the uneventful pipeline deployment, there was no stasis and class 3 raymond roy.The #2: the aneurysm is in the right, middle cerebral artery, bifurcation branch.It was saccular in shape.The max diameter was 2mm, dome height was 1mm, width of 2mm, and the neck was 2mm.The patient has a family history of strokes / tia and is a current smoker.The antiplatelet medications administered were p2y12 inhibitor 75mg/day, gpiib/iiia inhibitor 4mg/day, py 12 inhibitor prasugrel 20mg/day, p2y12 inhibitor 10mg/day, aspirin 75mg/day.

• Brand Name: PIPELINE FLEX
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: gabriela mclellan ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 8065171
• MDR Text Key: 126972303
• Report Number: 2029214-2018-00936
• Device Sequence Number: 1
• Product Code: OUT
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2018

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 Expiration Date: 01/31/2020
• Device Model Number: PED-300-14
• Device Catalogue Number: PED-300-14
• Device Lot Number: A407771
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/13/2018
• Date Device Manufactured: 01/31/2017
• 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): Hospitalization
• Patient Age: 66 YR