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); Paralysis (1997); Visual Disturbances (2140); Dysphasia (2195)

Event Date 02/17/2015

Event Type  Death  

Event Description

Mitha ap, mynard jp, storwick ja, shivji zi, wong jh, morrish w.Can the windkessel hypothesis explain delayed intraparenchymal haemorrhage after flow diversion? a case report and model-based analysis of possible mechanisms.Heart, lung and circulation.2015;24(8):824-830.Doi:10.1016/j.Hlc.2015.02.001.Medtronic literature review found a report of patient complications in association with a pipeline stent and a marksman microcatheter.The purpose of this article was to present a case of delayed hemorrhage after placement of a pipeline stent, discuss the proposed mechanisms, and describe a novel electrical analogue model that was used to evaluate the likely hemodynamic effect of stent placement.The article does not state any technical issues during use of the pipeline or marksman.The patient developed delayed ipsilateral intraparenchymal hemorrhage (iph) following the procedure.No wire perforation was noted during fluoroscopy and no extravasation of contrast was noted at any point during the procedure.Two 4.5 mm x 20 mm pipeline stents were implanted in a telescoping fashion across the proximal cavernous portion of the ica without complication, resulting in stagnation of flow within the aneurysm.The patient awoke from general anesthetic with no immediate postoperative neurologic concerns were noted; therefore, no immediate post-operative imaging was performed.At 0630 h on the first postoperative day (12 hours post-procedure) the patient developed sudden onset of right-sided hemiplegia, aphasia, and a fixed, dilated right pupil.Mannitol was administered, and the patient was immediately intubated and taken for ct/cta of their brain.Imaging revealed an acute 6x4 cm intraparenchymal hemorrhage in the left striatocapsular region with significant midline shift and uncal herniation.The patient passed away while in hospice care.

Manufacturer Narrative

See manufacturer report # 2029214-2023-00448 for another report from this article.Mitha ap, mynard jp, storwick ja, shivji zi, wong jh, morrish w.Can the windkessel hypothesis explain delayed intraparenchymal haemorrhage after flow diversion? a case report and model-based analysis of possible mechanisms.Heart, lung and circulation.2015;24(8):824-830.Doi:10.1016/j.Hlc.2015.02.001.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: 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: 16524732
• MDR Text Key: 311088881
• Report Number: 2029214-2023-00449
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• 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: 03/03/2023
• 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