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 Hematoma (1884); Hemorrhage/Bleeding (1888); Visual Disturbances (2140); Post Operative Wound Infection (2446); Pseudoaneurysm (2605); Thromboembolism (2654); Retroperitoneal Hemorrhage (4483)

Event Date 07/28/2023

Event Type  Injury  

Event Description

Salem mm, khorasanizadeh m, nwajei f, et al.Predictors of aneurysmal occlusion following intracranial aneurysms treatment with pipeline embolization device.Acta neurochirurgica: the european journal of neurosurgery.2023;165(10):2801-2809.Doi:10.1007/s00701-023-05740-1 medtronic literature review found a report of  thromboembolic complications, hemorrhage, and groin hematoma, femoral pseudoaneurysm, retroperitoneal bleeding, groin site infection, and visual disturbances in association with pipeline embolization device flow diversion.The purpose of this article was to determine the impact blood pressure has on flow diversion implantation with the ped and occlusion status of the aneurysm at follow up.The authors reviewed 310 cases of patients treated for aneurysms using flow diversion with the pipeline embolization device (ped).Of the 294 patients, the average age was 59 years, 235 were female and 59 were male.Hypertension status was addressed prior to the study and found of the 294 patients, 106 patients had an established hypertension diagnosis and were on anti-hypertension medication and 182 patients had an average systolic blood pressure of >130 (over 3 measurements).Hypertension in patients was associated with a trend toward increased odds for complete occlusion of the aneurysm but was not statistically significant.The article states balloon angioplasty was required in 17 cases and adjunct coiling was required in 10 cases.In addition, the mrs scores for patients at the last follow up included 191 patients mrs score was 0, 128 patients mrs score was 1-2, 10 patients mrs score was 3-5, and 2 patients mrs score was 6.At follow up, 257 aneurysms were completely occluded, 17 aneurysms were found to be near-complete occlusion, and 57 aneurysms were incompletely occluded.The following intra- or post-procedural outcomes were noted: thromboembolic complications in 17 cases hemorrhage in 8 patients groin hematoma in 8 patients femoral pseudoaneurysm in 4 patients retroperitoneal bleeding in 4 patients groin site infection in 2 patients visual disturbances (floaters) 3 patients.

Manufacturer Narrative

Continuation of d10: product id nv unk pipeline (unknown); product type: ; implant date n/a; explant date n/a product id unk-nv-rfx (unknown); product type: ; implant date n/a; explant date n/a g2: citation: authors: salem, m.M., khorasanizadeh, m., nwajei, f., gomez-paz, s., akamatsu, y., jordan, n., maroufi, s.F., thomas, a.J., ogilvy, c.S., <(>&<)> moore, j.M.Predictors of aneurysmal occlusion following intracranial aneurysms treatment with pipeline embolization device.Acta neurochirurgica: the european journal of neurosurgery, 165(10):2801-2809 2023.Doi:10.1007/s00701-023-05740-1 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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: 18359996
• MDR Text Key: 330933926
• Report Number: 2029214-2023-02408
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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: 12/05/2023
• 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
• Treatment: SEE H10...
• Patient Outcome(s): Other