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

Model Number NV UNK PIPELINE

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Vasoconstriction (2126)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Linfante, i., andreone, v., ravelo, n., starosciak, a.K., arif, b., shallwani, h., tze man kan, p., mcdermott, m.W., dabus, g.(2020).Endovascular treatment of giant intracranial aneurysms.Cureus, 12(5), e8290.Https://doi.Org/10.7759/cureus.8290 abstract objective: giant intracranial aneurysms (gias) are associated with a high risk of rupture and have a high mortality rate when they rupture (65-100%).The traditional microsurgical approach to secure these lesions is challenging, and as such endovascular embolization has been increasingly selected as a treatment option.Methods: we performed a retrospective analysis of consecutive patients with ruptured and unruptured gias at three medical centers from october 2008 to april 2016.Clinical follow-up and digital subtraction angiography were conducted at six months post-treatment.Chi-square analysis was used to determine differences in outcomes between anterior and posterior circulation aneurysms and if a pipeline embolization device (ped) provided favorable outcomes in unruptured gias.Results: a total of 45 consecutive patients (mean/median age = 57/59; range: 16-82 years) were included.The mean/median aneurysm size was 29.9/28.3 mm (range: 25-50 mm).Eight (18%) patients presented with aneurysmal subarachnoid hemorrhage and 37 (82%) with unruptured gias.Twenty-eight (62%) were treated with a ped: 11 (24.4%) with one ped, 1 (2.2%) with ped + coils, 11 (24.4%) with more than one ped, and 5 (13.5%) with multiple ped + coils.The overall mortality rate was 3/45 (6.7%).No deaths were procedure-related.Five (11.1%) patients experienced ischemic stroke but only 2 had a 90-day modified rankin scale (mrs) score of =3.Of 33 patients available for six-month angiography, raymond scale (rs) scores were 1, 2, and 3 for 23/45 (70%), 7/45 (20.9%), and 3/45 (9.1%), respectively.Chi-square test demonstrated that overall, anterior circulation gias had better clinical (mrs score) and radiographic (rs score) outcomes than posterior gias.Ped alone provided similar clinical mrs outcomes but had a higher rate of complete occlusion at six months compared with ped + coils and coils alone in unruptured gias (p < 0.05).Conclusions: endovascular embolization using ped or ped + coils appears to be a moderately safe and effective treatment option for patients with gias.It was reported that in one case at the three month follow-up it was observed that there was foreshortening of the ped braid into the aneurysm.The patient's baseline mrs was 3 and mrs remained a 3 at that three month follow-up.A follow-up procedure was completed to implant a second ped to address the issue and the patient's condition had improved at 9 month follow-up with mrs of 1.

Event Description

Additional information received from a healthcare provider (hcp) indicated the adverse events reported in the manuscript are not related to any medtronic products.

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.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
• MDR Report Key: 11017257
• MDR Text Key: 225569494
• Report Number: 2029214-2020-01315
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NV UNK PIPELINE
• Device Catalogue Number: NV UNK PIPELINE
• Device Lot Number: NOT-RPT
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention