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

Model Number NV UNK PIPELINE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Hemorrhage/Bleeding (1888); Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891); Seizures (2063); Pseudoaneurysm (2605); Convulsion/Seizure (4406)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Griffin a, reese v, hüseyinoglu z, et al.Predictors of clinical outcome after treatment of intracranial aneurysms with the pipeline embolization device. world neurosurgery.2019;130:e666-e671.Doi:10.1016/j.Wneu.2019.06.185.Medtronic received a literature article pertaining to a study to identify predictors of adverse events associated with the pipeline.In this study the mean age was 56.3, 80% female.The study took place between january 2014 and september 2018.204 aneurysms in 170 patients were treated with the pipeline.181 aneurysms were located in the anterior circulation, and 23 were found in the posterior circulation.82% of aneurysms were saccular, followed by 11% fusiform and 4% blister.(11%).The mean aneurysm size was 8.2mm.The overall complication rate was 13.5%.These complications included 5 strokes, 3 intraparenchymal hemorrhages, 3 groin hematomas, 2 retroperitoneal hematomas, 2 health care associated pneumonia.2 in-stent thrombosis.2 vessel perforations, 1 retinal artery occlusion.1 seizure, 1 groin pseudoaneurysm, and 1 aneurysm rupture.The major neurologic morbidity rate was 4.7%, occurring in 8 patients.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 9860842
• MDR Text Key: 191391930
• Report Number: 2029214-2020-00267
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• 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: 56 YR
• Patient Sex: Female