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 01/01/2015

Event Type  Death  

Manufacturer Narrative

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

Event Description

J intervent radiol 2018, vol.27, no.8.The utilization of pipeline flow- diverter device in treating large cerebral aneurysms in chinese: analysis of perioperative complications.He yingkun, li tianxiao, li hang, bai weixing, xu bin, kang xiaoyu.Section of cerebrovascular diseases, interventional center, people's hospital of zhengzhou university.Information was received from a literature article regarding 22 patients implanted with a pipeline device for treatment of a large cerebral aneurysm.In the study three patients developed perioperative complications, of them one died due to postoperative ruptured aneurysm bleeding, one patient had non-disabled cerebral intraparenchymal hemorrhage, and one patient had non- disabled hyperperfusion syndrome.

• 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: 9212500
• MDR Text Key: 162963505
• Report Number: 2029214-2019-01039
• 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
• 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