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

Model Number NV UNK PIPELINE

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

Patient Problem Aneurysm (1708)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Reported patient age ((b)(6)) is representative of the mean age of all patient included in the study.Reported patient sex (female) is representative of the majority of patients included in the study.If information is provided in the future, a supplemental report will be issued.

Event Description

Park, k.Y., yeon, j.Y., kim, b.M., jeon, p., kim, j.-h., jang, c.K., kim, d.J., lee, j.W., kim, y.B., chung, j., song, d.H., park, h.G., <(>&<)> park, j.S.(2020).Efficacy and safety of flow-diverter therapy for recurrent aneurysms after stent-assisted coiling.Ajnr.American journal of neuroradiology, 41(4), 663¿668.Https://doi.Org/10.3174/ajnr.A6476.Abstract background and purpose: flow-diverter treatment for previously stented aneurysms has been reported to be less effective and prone to complications.In this study, we evaluated the effectiveness and safety of flow diverters for recurrent aneurysms after stent-assisted coiling.Materials and methods: patients who underwent flow-diverter placement for recurrent aneurysms after stent-assisted coiling between march 2015 and march 2019 were recruited.Clinical and radiographic characteristics and clinical and angiographic outcomes were retrospectively evaluated.Results: among 133 patients who underwent flow-diverter insertion, 17 (male/female ratio = 5:12; mean age, 53.8 years) were treated for recurrent aneurysms after stent placement with (n ¼ 16) or without (n ¼ 1) coiling.Eight patients initially presented with subarachnoid hemorrhage; 7, with headache; and 2, with visual field defects.Angiographic morphology included large/giant saccular in 12 patients, dissecting in 2, fusiform in 1, traumatic pseudoaneurysm in 1, and ruptured blood blister-like aneurysm in 1.The duration between the first treatment and flow-diverter placement ranged from 2 weeks to 15 months (median, 6 months).Flow-diverter placement was successful in all cases without any complications.All patients had favorable outcomes (mrs, 0¿2), without any newly appearing symptoms.Aneurysms were followed up with conventional angiography at least once in 6¿18 months.Sixteen aneurysms showed complete occlusion, and 1 aneurysm was enlarged.Conclusions: results from this case series investigating flow-diverter placement for recurrent aneurysms after stent-assisted coiling suggested that the procedure is safe and effective.Further study in a larger population may be warranted.Medtronic review of the literature article found that both pipeline classic and pipeline flex devices were used and it was not specified in which cases what device was used.All procedures were considered successful.All patients had favorable outcomes and there were no new neurological deficits.In only one case, the middle cerebral artery (mca) dissecting aneurysm was observed to be enlarged during follow-up.The patient underwent a third procedure to place an additional flow-diverter.

• 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: 13558954
• MDR Text Key: 286141049
• Report Number: 2029214-2022-00236
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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: 01/28/2022
• 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): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female