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

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

Citation: i.Szikora, z.Berentei, z.Kulcsar, et al.Treatment of intracranial aneurysms by functional reconstruction of the parent artery: the budapest experience.Ajnr am j neurodadiol.2010.The devices will not be returned for evaluation as they were implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The event occurred in the patients post procedure and the cause was unknown.Mdrs related to this report: 2029214-2017-00342, 2029214-2017-00343.

Event Description

Medtronic received information through review of literature that clinical complications occurred in four cases.One patient had a mild postprocedural hemiparesis lasting for 2 days.The patient fully recovered, and no ischemic changes were seen on ct.This event was primarily considered the result of contrast overload due to difficulties of catheter navigation and a lengthy procedure, but a ct negative thromboembolic complication could not be excluded.One patient had an embolic occlusion of a retinal artery branch, resulting in a small visual field deficit following ped-supported coil packing of her complex paraophthalmic aneurysm.One patient who we subsequently learned had not taken her antiplatelet medication experienced acute intraprocedural in-stent thrombosis within the internal carotid artery (ica).It was initially recanalized with tirofiban (aggrastat) but re-occluded 2 days later, despite being treated with double antiplatelets.The patient had a transient hemiparesis.Having good collateral circulation, she fully recovered and the ica later recanalized.One patient experienced abrupt in-stent thrombosis resulting in a transient neurologic deficit.

• Brand Name: PIPELINE
• 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6451347
• MDR Text Key: 71459412
• Report Number: 2029214-2017-00342
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• 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: 03/03/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability