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

Model Number NV UNK PIPELINE

Device Problem No Apparent Adverse Event (3189)

Patient Problems Hematoma (1884); Hemorrhage, Cerebral (1889); Hemorrhage, Subarachnoid (1893); Occlusion (1984); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Mohammad seyedsaadat s, rangel castilla l, lanzino g, et al.Remote ischemic preconditioning for elective endovascular intracranial aneurysm repair: a feasibility study. the neuroradiology journal.2019;32(3):166-172.Doi:10.1177/1971400919842059.Medtronic received a report via a literature article which was used to delineate the risk estimates for unruptured intracranial aneurysms treated with the pipeline based on patients risk profiles.In the study the mean patient age was (b)(6), 77% of participants were female, and the mean lesion size was 7.3 mm.A pipeline embolization device was used in 248 patients total.It was reported that there was one case of subarachnoid hemorrhage during placement of pipeline.Two patients had ischemic cerebellar stroke and groin hematoma.One patient had permanent visual field loss and groin oozing after pipeline placement.There were also two cases of in-stent thrombosis which cleared with eptifibatide, and a subsequent subarachnoid hemorrhage after procedure.

• 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: 9853303
• MDR Text Key: 189287916
• Report Number: 2029214-2020-00257
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100018.S004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• 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
• Date Manufacturer Received: 03/05/2020
• 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; Required Intervention
• Patient Age: 59 YR