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 Death (1802); Intracranial Hemorrhage (1891); Therapeutic Response, Decreased (2271)

Event Date 01/01/2010

Event Type  Death  

Manufacturer Narrative

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

Event Description

Academic journal of second military medical university, mar.2019, vol.40, no.3.Flow diverters in treatment of complex intracranial aneurysms: a single-center experience.Lü nan, zhou yu, yang peng-fei, fang yi-bin, li qiang, zhao rui, zhao kai-jun, xu yi, hong bo, huang qing-hai, liu jian-min.Department of neurosurgery, changhai hospital, naval medical university (second military medical university), shanghai, china.Medtronic received a report from a literature article regarding 42 patients treated with a pipeline device for treatment of complex intracranial aneurysms.The patients were treated between aug 2010 and dec 2017.The mean maximum diameter of the aneurysms was 19.6 mm.All 42 patients had the pipeline successfully implanted.1 patient died of delayed hemorrhage, and 2 patients suffered from ischemic events after operation.The complete occlusion rates of short-term (0-6 months), mid-term (7-18 months) and long term (>18 months) were 66.7%, 73.5%, and 89.3% respectively.The complete occlusion rate of all aneurysms was 72.7%.

• 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: 9212611
• MDR Text Key: 162964221
• Report Number: 2029214-2019-01040
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2019
• 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
• 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): Death