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 Effects, Unexpected (2099)

Event Date 01/18/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

On 2017-jan 18.Effect analysis of embolization device for the treatment of large or giant intracranial aneurysms.Chin j cerebrovasc dis, jan.18, 2017,vol.14,no.1.Feng mingtao ,cao wei,li jia' nan,yang pengfei,fang yibin,xu yi,hong bo,huang qinghai,liu jianmin.Department of neurosurgery,changhai hospital,the second military medical university.Information was received from a literature article to evaluate the safety of pipeline for treatment of large and giant intracranial aneurysms.33 patients were evaluated, with 35 aneurysms total.10 were implanted with pipeline alone, and 25 with pipeline and coiling.During the perioperative period, 1 aneurysm resulted in intracranial hemorrhage and 1 patient died from delayed bleeding.31 patients were followed up clinically and no bleeding or thrombosis events occurred.Short-term postoperative imaging showed 12 aneurysms had neck residue or aneurysm development, 8 did not develop at all.

• 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: 9212498
• MDR Text Key: 162969950
• Report Number: 2029214-2019-01038
• 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