MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-REBAR

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

Patient Problems Headache (1880); Blurred Vision (2137); Post Operative Wound Infection (2446); Pseudoaneurysm (2605); Swelling/ Edema (4577)

Event Date 10/06/2022

Event Type  Injury  

Event Description

Raynald, yang,h., tong, x.,huo, x., li, x., liu, l., sui, b., qu, h., dong, k., wang, y., wang, s., miao, z., mo, d.Stenting versus medical treatment for idiopathic intracranial hypertension: a matched-control study.J neurointervent surg.2023.15:1021¿1026.Doi: 10.1136/neurintsurg-2022-019191 summary: this prospective cohort study compared the outcomes of stenting and medical treatment for patients with idiopathic intracranial hypertension (iih) and venous sinus stenosis (vss).In this single-center cohort study, patients with iih and vss were evaluated between january 2014 and december 2019 with follow-up periods of 1, 3, and 6 months.The patients received either stenting or medical treatment.The two groups underwent 1:1 matching using propensity score analysis, and the clinical outcomes were compared.Following 1:1 matching, 36 patients who underwent stenting and 36 who underwent medical treatment were matched.The median improvements in the papilledema frisén grade were greater in the stenting group at 1month (-2 vs 0), 3 months (-3 vs -1), and 6 months (-3 vs -1) than in the medical treatment group.Patients who received stenting treatment had a significantly higher prevalence of complete resolution of their respective symptoms (headache, tinnitus, or visual disturbances) at 3 months (58.3% vs 13.9%, or 8.68, 95% ci 2.74 to 27.52) and 6 months (80.6% vs 22.2%, or 14.50, 95%ci 4.64 to 45.32) than those receiving medical treatment.This matched-control study shows that stenting has a greater efficacy rate and rapid resolution of papilledema and its respective symptoms compared with medical treatment.Reported events: after the stenting treatment, 24 patients had gastrointestinal discomfort, 11 patients had menorrhagia, three patients had gingival bleeding, and one patient had fundus hemorrhage.Pulmonary infection occurred in one patient.A pseudoaneurysm at the femoral puncture site was found in one patient.Of all the patients who received stenting treatment, three received a second stent placement.One patient had bilateral papilledema and a second stent was placed at the contralateral venous sinus.Another patient showed improved symptoms after stent placement, with the symptoms worsening later.One year after stenting significant re-stenosis was observed and further stent placement was performed.In another patient, symptoms improved after the first stent placement; however, there was no resolution of the papilledema and occasional headache and blurred vision remained.Three months later, a second stent placement was performed and no worsening of blurred vision was observed.

Manufacturer Narrative

No specific device information provided.No event date was provided the event date used was the date the article was published.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• 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: 19130438
• MDR Text Key: 340447335
• Report Number: 2029214-2024-00680
• Device Sequence Number: 1
• Product Code: KRA
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-REBAR
• Device Catalogue Number: UNK-NV-REBAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/18/2024
• 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): Life Threatening