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

Model Number UNK-NV-MARKSMAN

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

Patient Problems Intracranial Hemorrhage (1891); Rupture (2208)

Event Date 11/12/2019

Event Type  Death  

Manufacturer Narrative

Reported patient age (53 years) is representative of the mean age of all patient included in the literature article study information.Reported patient sex (female) is representative of the majority of patients (17/22) who were included in the literature article study information.Associated with mdr #: 2029214-2022-02090.Separate reports will be submitted for the echelon microcatheter and navien intracranial support catheters and for the serious injury event(s) reported in the article.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

Wang, z., tian, z., li, w., wang, j., zhu, w., zhang, m., zhang, y., liu, j., wang, k., zhang, y., <(>&<)> yang, x.(2019).Variation of mass effect after using a flow diverter with adjunctive coil embolization for symptomatic unruptured large and giant intracranial aneurysms.Frontiers in neurology, 10, 1191.Https://doi.Org/10.3389/fneur.2019.01191 medtronic review of the literature article found that 22 patients with 22 unruptured large or giant aneurysms with related mass effe ct/compression symptoms were treated with flow diverter with loose adjunctive coiling.17/22 patients were female and the mean patient age was 53 years.The pipeline embolization device (ped) was noted to be the most commonly used flow diverter at the facility.It was additionally noted that 5f navien intracranial support catheter, marksman microcatheter, and echelon microcatheter were used in the flow diverter + coiling procedures.Multiple manufacturer's coil were used, including axium coils.However, the type of coils used in each event was not specified.There were no reported device malfunctions or intra-operative issues.Adverse patient events noted in the article included: five of the 22 patients (22.72%) showed no improvement of aneurysm size/status post-operatively.Four patients (18.18%) showed worsening neurological symptoms compared with their preoperative status, including two (9.09%) with ischemic complications.All four of these patients presented with more severe compressional symptoms than their preoperative state.One patient (4.55%) died of subarachnoid hemorrhage related to delayed aneurysm rupture diagnosed at a local center 2 months post-operatively.

• Brand Name: MARKSMAN
• 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: 15950703
• MDR Text Key: 305170794
• Report Number: 2029214-2022-02091
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K111490
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-MARKSMAN
• Device Catalogue Number: UNK-NV-MARKSMAN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• 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): Death
• Patient Age: 53 YR
• Patient Sex: Female