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 Death (1802); Intracranial Hemorrhage (1891)

Event Date 01/23/2019

Event Type  Death  

Manufacturer Narrative

The pipeline device will not be returned for evaluation as it was implanted in the patient.The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.Mdrs related to this article: 2029214-2019-01072.If information is provided in the future, a supplemental report will be issued.

Event Description

Primiani, c.T., ren, z., kan, p., hanel, r., pereira, v.M., lui, w.M., ¿ mokin, m.(2019).A2, m2, p2 aneurysms and beyond: results of treatment with pipeline embolization device in 65 patients.Journal of neurointerventional surgery, 11(9), 903¿907.Doi: 10.11 36/neurintsurg-2018-014631 medtronic literature review found reports of patient complications after pipeline placement.The purpose of this article was to describe the results of pipeline treatment of distal intracranial aneurysms.The authors reviewed the results of 65 patients with distal aneurysms treated with pipeline.Of the 65 patients, the mean age was 54.7 years; 42 of the patients were female.The article notes the following events: - one patient underwent pipeline placement in the treatment of a saccular, m2 aneurysm.The experienced ipsilateral hemorrhage within the first 24 hours post-procedure.The patient underwent decompressive craniectomy and hematoma evacuation.The patient passed away within 3 months.

• 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 ; 9496801345
• MDR Report Key: 9235911
• MDR Text Key: 163701878
• Report Number: 2029214-2019-01071
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• 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: 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