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 Hematoma (1884); Hemorrhage/Bleeding (1888); Vasoconstriction (2126); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 12/14/2020

Event Type  Injury  

Event Description

Borggrefe, j., goertz, l., abdullayev, n., hokamp, n.G., kowoll, c.M., onur, ö., kabbasch, c., <(>&<)> schlamann, m.(2021).Mechanical thrombectomy with the novel neva m1 stent retriever: do the drop zones represent a risk or a benefit? world neurosurgery, 148.Https://doi.Org/10.1016/j.Wneu.2020.12.075 summary: the neva m1 thrombectomy device is a novel hybrid-cell stent retriever with multifunctional zones for optimized retrieval of resistant clotslocatedinthem1 segment of the middle cerebral artery.The objectivewasto evaluate the safety and efficacy of the neva in a ¿real-life¿ setting.Identified events: 1.1 patient exhibited extensive calcifications of the cavernous carotid artery bilaterally.The fistula was successfully covered with a pipeline flex embolization device with shield technology.2.1 patient had a dissection of the m2 segment which occurred after successful thrombectomy.The patient remained asymptomatic and was treated by administration of acetylsalicylic acid 100mg per day for 6 months.3.11 patients had hemorrhagic infarction 1.4.3 patients had hemorrhagic infarction 2.5.2 patients had parenchymal hematoma 1.6.1 patient had parenchymal hematoma 2.7.14 patients had vasospasms.The stent retrievers were used in combination with a distal aspiration catheter (axs catalyst 5; stryker neurovascular, fremont, california, usa) or a 5f/6f sofia catheter (microvention, tustin, california, usa).The microcatheters used were rebar 18 or headway 21.Trevo (stryker), solitaire (medtronic, irvine, california, usa), aperio hybrid (acandis, pforzheim, germany) stent retrievers, and the jet 7 reperfusion catheter (penumbra, alameda, california, usa) were used for rescue therapy.

Manufacturer Narrative

Borggrefe, j., goertz, l., abdullayev, n., hokamp, n.G., kowoll, c.M., onur, ö., kabbasch, c., <(>&<)> schlamann, m.(2021).Mechanical thrombectomy with the novel neva m1 stent retriever: do the drop zones represent a risk or a benefit? world neurosurgery, 148.Https://doi.Org/10.1016/j.Wneu.2020.12.075 pt age: this value is the average age of the patients reported in the article as specific patients could not be identified.Pt gender.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Event date: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Associated regulatory report: 2029214-2022-01029.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: 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: 14744797
• MDR Text Key: 294414204
• Report Number: 2029214-2022-01030
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• 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: 77 YR
• Patient Sex: Female