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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Thromboembolism (2654)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.Griessenauer cj, enriquez-marulanda a, xiang s, et al.Comparison of ped and fred flow diverters for posterior circulation aneurysms: a propensity score matched cohort study.Journal of neurointerventional surgery published online first: 01 july 2020.Doi: 10.1136/neurintsurg-2020-016055.If information is provided in the future, a supplemental report will be issued.

Event Description

Griessenauer cj, enriquez-marulanda a, xiang s, et al.Comparison of ped and fred flow diverters for posterior circulation aneurysms: a propensity score matched cohort study.Journal of neurointerventional surgery published online first: 01 july 2020.Doi: 10.11 36/neurintsurg-2020-016055.Medtronic literature review found reports of patient complications in association with pipeline implantation for treatment of aneurysms of the posterior circulation.The purpose of the article was to perform a propensity score matched cohort study comparing the pipeline embolization device (ped) and flow redirection intraluminal device (fred) for posterior circulation aneurysms.The authors reviewed a total of 375 treated aneurysms in 369 patients.The pipeline was used in 285 patients.Of the 285 patients, the average age was 57 years, and 147 female.The article does not state any technical issues during the use of the pipeline.In addition, 242 patients had an mrs score of less than or equal to 2 on the last follow-up.The following intra- or post-procedural outcomes were noted: 37 patients experienced thromboembolic complications per procedure.14 patients experienced hemorrhagic complications per procedure.

Manufacturer Narrative

D3: manufacturer name and address inadvertently omitted on initial report.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.

Event Description

Griessenauer cj, enriquez-marulanda a, xiang s, et al.Comparison of ped and fred flow diverters for posterior circulation aneurysms: a propensity score matched cohort study.Journal of neurointerventional surgery published online first: 01 july 2020.Doi: 10.11 36/neurintsurg-2020-016055.Medtronic literature review found reports of patient complications in association with pipeline implantation for treatment of aneurysms of the posterior circulation.The purpose of the article was to perform a propensity score matched cohort study comparing the pipeline embolization device (ped) and flow redirection intraluminal device (fred) for posterior circulation aneurysms.The authors reviewed a total of 375 treated aneurysms in 369 patients.The pipeline was used in 285 patients.Of the 285 patients, the average age was 57 years, and 147 female.The article does not state any technical issues during the use of the pipeline.In addition, 242 patients had an mrs score of less than or equal to 2 on the last follow-up.The following intra- or post-procedural outcomes were noted: 1.37 patients experienced thromboembolic complications per procedure.2.14 patients experienced hemorrhagic complications per 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
• MDR Report Key: 10319646
• MDR Text Key: 203699879
• Report Number: 2029214-2020-00720
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR