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

Model Number NV UNK PIPELINE

Device Problem Positioning Failure (1158)

Patient Problems Intracranial Hemorrhage (1891); Nerve Damage (1979); Paresis (1998); Obstruction/Occlusion (2422); Syncope/Fainting (4411); Thrombosis/Thrombus (4440)

Event Date 11/03/2022

Event Type  Death  

Event Description

2023-jan-24 lit (hcp, for): tong x, he z, han m, feng x, duan c, liu a.Flow diversion treatment for giant intracranial serpentine aneurysms.Frontiers in aging neuroscience.2022;14:988411.Doi:10.3389/fnagi.2022.988411.Medtronic literature review found reported of death, subarachnoid hemorrhage, thrombotic events leading to progressive right hemiparesis, right abducens nerve palsy, and loss of consciousness, and parent vessel occlusion in association with pipeline flow diverter treatment.The purpose of this article was to determine the efficacy of using flow diversion in treating great serpentine aneurysms.The authors reviewed 13 cases of patients treated for great serpentine aneurysms using flow diversion.Of the 13 patients, the average age was 60 years, 2 were female and 11 were male.Presenting symptoms were headache, hemiparesis, subarachnoid hemorrhage (sah), blurred vision, and loss of consciousness.The article does state one event with a technical issue during the use of the pipeline.In the article it states  "however, other fd devices cannot be successfully placed owing to the extremely twisted morphology of the parent vessel." in addition, the o'kelly- marotta scale showed grades b-d in 72.7% of patients and a good prognosis with a mrs score of 0-2 in 66.7% of patients.The following intra- or post-procedural outcomes were noted: -one patient with bilateral internal carotid artery (ica) great serpentine aneurysms treated with a flow diverter device developed b ilateral ica occlusion and died after 5years.-one patient refused to take antiplatelet medication and died from an ischemic stroke -five postoperative complications: a.Subarachnoid hemorrhage leading to death in the hospital b.Progressive right hemiparesis with loss of consciousness from a thrombotic event c.Progressive loss of consciousness from a thrombotic event d.Right hemiparesis from a thrombotic event e.Right abducens nerve palsy from a thrombotic event -parent artery occlusion found in 3 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.

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: 16253563
• MDR Text Key: 308257144
• Report Number: 2029214-2023-00124
• 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,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• 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: 01/24/2023
• 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): Death