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

Model Number NV UNK PIPELINE

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem Occlusion (1984)

Event Date 03/26/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Yupeng zhang, fei liang, yuxiang zhang, peng yan, shikai liang, chao ma and chuhan jiang.Exploring the feasibility of pipeline embolization device compared with stent-assisted coiling to treat non-saccular, unruptured, intradural vertebral artery aneurysms.Doi: 10.3389/fneur.2019.00275.Medtronic literature review found a report of complications after the use of pipeline.The purpose of the article was to explore the therapeutic feasibility of ped by comparing ped treatment with controlled stent-assisted coiling (sac).The percentage proportion of female patients was 18.8 in the ped group.Median patient age was similar in the ped group [51 years (47¿58)].- technical events occurred in 3 (9.4%) procedures (two insufficient opening of stent (>50%), one foreshortening of stent).The pipeline embolization device (ped) was not fully deployed in two patients because of stenosis of the parent artery, which caused parent artery occlusion.Fortunately, both patients were asymptomatic with patency of the covered posterior inferior cerebellar arteries (picas) at final angiographic follow-up.Foreshortening of the ped that occurred in the procedure did not cover the target aneurysms.An additional ped was deployed.The aneurysm is completely occluded with parent artery patency at final angiography.

• 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: 9856685
• MDR Text Key: 196387819
• Report Number: 2029214-2020-00263
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-REP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2020
• 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