MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY SEPS; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 11-0401-CAL

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

Patient Problem Fistula (1862)

Event Date 10/10/2023

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

J.Scaggiante, a.Devarajan, m.T.Caton, t.Shigematsu, t.Oxley, s.Majidi, c.P.Kellner, j.Fifi, a.Berenstein, r.De leacy, j.Mocco, h.Shoirah.Incidence of dural arteriovenous fistulas during middle meningeal artery embolization for the treatment of chronic subdural hemorrhage.International journal of stroke 18 (2023).Background and aims: chronic subdural hematoma(csdh) affects mainly elderly individuals, secondary to multiple comorbidities and risk factors.Middle meningeal artery(mma) embolization is an emerging procedure which may reduce the recurrence rates of sdh.Authors noted occult dural arteriovenous fistulas(davf)during mma embolization and our goal was to investigate their incidence.Methods: a retrospective analysis was conducted on patients who underwent mma embolization for csdh between 2019-2022.We reviewed de mographics, clinical presentation,radiological findings and treatment outcomes.Occult davf were defined as abnormal arteriovenous shunts on baseline catheter-based angiography of the external carotid artery, not evident on non-invasive imaging.Results: in 8 patients out of 225, 11 occult davfs were found(4.9%).The incidence was higher in male patients(7/8,87.5%) with a history of head trauma(87.5%).10/11 davf were spontaneous,while 1 fistula developed after subdural evacuation port system(seps).Median age was 82.5 y.O.In 8/11 patients(73%) the occult fistula was between the posterior mma branchand the transverse sinus.Others between the petrosal branch and transverse sinus, between the anterior frontal branch and the middle meningeal vein or the anterior branch and the superior sagittal sinus.10/11 davfs were cognard type-1 fistulas,1/11 was type-3.6/11(54.5%) required treatments:3/6 n-bca embolization;2/6 coiling,1/6 open surgery.Conclusions: we reported a high incidence of occult davf in patients with csdh demonstrated with catheter-based angiography who had no underlying vascular abnormality with non-invasive imaging.It is unclear whether such fistulae may have predated and possibly contributed to the formation of the csdh, or whether the presence of csdh may promote the formation or augmentation of latent fistulae.More studies about the pathophysiological significance of these findings are warranted.Reported event - 1 fistula developed after subdural evacuation port system (seps).

• Brand Name: SEPS
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18526922
• MDR Text Key: 333043380
• Report Number: 2021898-2024-00055
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11-0401-CAL
• Device Catalogue Number: 11-0401-CAL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• 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): Other