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 Hemorrhage/Bleeding (1888); Intracranial Hemorrhage (1891); Ischemia (1942)

Event Date 11/02/2020

Event Type  Injury  

Event Description

Luo, b., kang, h., zhang, h., li, t., liu, j., song, d., zhao, y., guan, s., maimaitili, a., wang, y., feng, w., wang, y., wan, j., mao, g., shi, h., yang, x.(2020).Pipeline embolization device for intracranial aneurysms in a large chinese cohort: factors related to aneurysm occlusion.Therapeutic advances in neurological disorders, 13, 1756286420967828.Https://doi.Org/10.1177/1756286420967828.Medtronic review of the literature article found a multi-center study to investigate the safety and effectiveness of the pipeline embolization device (ped) for treatment of intracranial aneurysms in the chinese population.1171 patients with 1322 intracranial aneurysms treated in 1319 procedures were included in the study.The average patient age was 53.9 ± 11.4 years and the majority of patient's included in the study were female (69.4%).685 aneurysms were treated with ped only and 637 aneurysms were treated with ped plus coiling.85 patients had post-operative ischemic complications.24 patients had subarachnoid hemorrhage post-operatively.23 patients had int raparenchymal hemorrhage post-operatively.

Manufacturer Narrative

Reported patient age ((b)(6)) is representative of the mean age of all patients included in the study.Reported patient sex (female) is representative of the majority of patients included in the study.If information is provided in the future, a supplemental report will be issued.

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13446096
• MDR Text Key: 285250685
• Report Number: 2029214-2022-00152
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2022
• 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
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Race: Asian