MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NV BALLOON; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number UNK-NV-BALLOONS

Device Problem No Apparent Adverse Event (3189)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 08/19/2016

Event Type  Injury  

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.

Event Description

Tang, x., long, w.A., hu, c., tang, f., wang, q., li, l.The modified ¿no touch¿ technique in the antegrade endovascular approach for left common carotid artery ostial stenosis stenting.J neurointervent surg 2017 9:137¿142.Doi:10.1136/neurintsurg-2016-012544 summary: open surgery and the retrograde endovascular approach via the distal left common carotid artery (lcca) have some limitations in lcca ostial stenosis treatment.The ¿no touch¿ technique used in the renal artery was modified for this situation.Fifteen selective lcca stenosis patients were treated by the modified ¿no touch¿ technique in the antegrade endovascular approach from march 2013 to march 2016.Thirteen underwent the transfemoral approach and the other two had the transbrachial approach due to a ¿bovine aortic arch¿.Distal embolic protection devices were used in all cases.Follow-up included a neurological examination, carotid duplex scan, and office interview.Mean follow-up time was 18.2±11.5 months.Results the initial technical success rate was 100%.The average procedure time was 84.0±16.3 min.There were no procedure-related deaths.No clinical neurological complications occurred during the inhospital stay.No incidence of death or major stroke occurred during the follow-up period; 6.7% (1/15) of patients had a contralateral minor stroke, 66.7% (4/6) of symptomatic patients were relieved of initial symptoms, and the rest showed improvement.No patient developed new ipsilateral neurological symptoms and no in-stent restenosis occurred during the follow-up period.These results were confirmed by ultrasound.The modified ¿no touch¿ antegrade endovascular technique is a feasible method for treating lcca ostial lesions with a satisfactory initial success rate, acceptable procedure time, and comparable midand long-term results.This technique could be considered as a complementary option for lcca ostial stenosis in addition to open surgery and the retrograde endovascular approach.Reported events: there were no procedure-related deaths or clinical neurological complications during the in-hospital stay.All patients received fol low-up care.No deaths occurred.However, 6.7% (1/15) of patients had a contralateral minor stroke, 66.7% (4/6) of symptomatic patients were relieved of initial symptoms, and the other two showed great improvement.No patient in the study developed new ipsilateral neurological symptoms.No in-stent restenosis (>30%) was found by ultrasound.

• Brand Name: NV BALLOON
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• 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: 16064245
• MDR Text Key: 306317806
• Report Number: 2029214-2022-02205
• Device Sequence Number: 1
• Product Code: MJN
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-BALLOONS
• Device Catalogue Number: UNK-NV-BALLOONS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2022
• 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): Life Threatening