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

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

Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942); Rupture (2208); Thromboembolism (2654)

Event Date 01/28/2019

Event Type  Injury  

Manufacturer Narrative

The pipeline devices have not been returned for evaluation; product analysis cannot be performed.The devices have not been returned; the reported events could not be confirmed.The causes of the events could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2019-00565, 2029214-2019-00567.If information is provided in the future, a supplemental report will be issued.

Event Description

Yan, p., zhang, y., liang, f., ma, c., liang, s., guo, f., & jiang, c.(2019).Comparison of safety and effectiveness of endovascular treatments for unruptured intracranial large or giant aneurysms in internal carotid artery.World neurosurgery, 125.Doi:10.1016/j.Wneu.2019.01.082.Medtronic literature review found reports of pipeline patient post-procedure events.The purpose of this article was to analyze and compare the safety and efficacy of different endovascular treatment modalities for unruptured intracranial large or giant aneurysms.The authors reviewed the results of 61 patients who underwent treatment with the pipeline embolization device (ped).Of the 61 ped patients, the article notes the following complications: - 5 hemorrhagic complications - 8 ischemic complications - 2 mass effect - 3 intraparenchymal hemorrhages - 5 thromboembolic complications - 2 ruptures.

• Brand Name: PIPELINE FLEX EMBOLIZATION DEVICE
• 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 ; 7635263305
• MDR Report Key: 8702186
• MDR Text Key: 148146680
• Report Number: 2029214-2019-00566
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100018.S011
• 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: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• 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: 05/16/2019
• 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