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

Model Number NV UNK PIPELINE

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

Patient Problems Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Optical Nerve Damage (1986); Therapeutic Effects, Unexpected (2099); Device Embedded In Tissue or Plaque (3165)

Event Date 11/01/2011

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Kole mj, miller tr, cannarsa g, et al.Pipeline embolization device diameter is an important factor determining the efficacy of flow diversion treatment of small intracranial saccular aneurysms.Journal of neurointerventional surgery.2019;11(10):1004-1008.Doi:10.1136/neurintsurg-2019-014792.Medtronic received a report from a clinical study through a literature article to investigate whether pipeline diameter influences treatment efficacy when using a single device.In this study there were 224 intrasaccular aneurysms in 185 patients were treated from nov 2011 to oct 2016.All aneurysms were in the anterior circulation, most form the internal carotid artery at or proximal to the posterior communicating artery origin.The average aneurysm size was 4.8mm.In this study 123 aneurysms were occluded over an average follow up of 26.6 months.Complications occurred including 6 instances of procedure-related morbidity.1 patient had bilateral punctate embolic infarctions following treatment, 1 developed what appeared to be foreign body granulomas throughout the ipsilateral cerebral hemisphere following pipeline placement.Both complications resolved without permanent neurological morbidity, but the second patient is maintained on corticosteroid therapy.1 patient experienced an ipsilateral occipital intraparenchymal hemorrhage post-procedure, resulting in a permanent quandrantanopsia.2 patients developed retroperitoneal hematomas that were treated conservatively, and a third patient developed a femoral artery pseudoaneurysm at the insertion site which was treated with percutaneous thrombin injection.

• Brand Name: PIPELINE
• 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: 9238981
• MDR Text Key: 173445816
• Report Number: 2029214-2019-01080
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-RPT
• 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
• Patient Age: 55 YR