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

Model Number UNKNOWN-C

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

Patient Problems Headache (1880); Paresis (1998); Visual Impairment (2138); Meningitis (2389); Ambulation Difficulties (2544)

Event Date 01/27/2024

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

Michael schmutzer-sondergeld, aylin gencer, sebastian niedermeyer, stefanie quach, veit m.Stoecklein, nico teske, christian schichor, nicole angela terpolilli, mathias kunz, niklas tho.Evaluation of surgical treatment strategies and outcome for cerebral arachnoid cysts in children and adults.Acta neurochirurgica 166 (2024).Doi: 10.1007/s00701-024-05950-1 abstract objective the best treatment strategies for cerebral arachnoid cysts (cac) are still up for debate.In this study, we present cac management, outcome data, and risk factors for recurrence after surgical treatment, focusing on microscopic/endoscopic approaches as compared to minimally invasive stereotactic procedures in children and adults.Methods in our single-institution retrospective database, we identified all patients treated surgically for newly diagnosed cac between 2000 and 2022.Microscopic/endoscopic surgery (me) aimed for safe cyst wall fenestration.Stereotactic implantation of an internal shunt catheter (stx) to drain cac into the ventricles and/or cisterns was used as an alternative procedure in patients aged = 3 years.Treatment decisions in favor of me vs.Stx were made by interdisciplinary consensus.The primary study endpoint was time to cac recurrence (ttr).Secondary endpoints were outcome metrics including clinical symptoms and mr-morphological analyses.Data analysis included subdivision of the total cohort into three distinct age groups (ag1, <(><<)> 6 years; ag2, 6¿18 years; ag3, = 18 years).Results sixty-two patients (median age 26.5 years, range 0¿82 years) were analyzed.Ag1 included 15, ag2 10, and ag3 37 patients, re spectively.The main presenting symptoms were headache and vertigo.In ag1 hygromas, an increase in head circumference and thinning of cranial calvaria were most frequent.Thirty-five patients underwent me and 27 stx, respectively; frequency did not differ between ags.There were two (22.2%) periprocedural venous complications in infants (4- and 10-month-old) during an attempt at prepontine fenestration of a complex cac, one with fatal outcome in a 10-month-old boy.Other complications included postoperative bleeding (2, 22.2%), csf leaks (4, 44.4%), and meningitis (1, 11.1%).Overall, clinical improvement and significant volume reduction (p = 0.008) were seen in all other patients; this did not differ between ags.Median follow-up for all patients was 25.4 months (range, 3.1¿87.1 months).Recurrent cysts were seen in 16.1%, independent of surgical procedure used (p = 0.7).In cases of recurrence, ttr was 7.9 ± 12.7 months.Preoperative ventricular expansion (p = 0.03), paresis (p = 0.008), and age under 6 years (p = 0.03) were significant risk factors for cac recurrence in multivariate analysis.Conclusions in patients suffering from cac, both me and stx can improve clinical symptoms at low procedural risk, with equal extent of cac volume reduction.However, in infants and young children, cac are more often associated with severe clinical symptoms, stereotactic procedures have limited use, and microsurgery in the posterior fossa may bear the risk of severe venous bleeding.Reported events - 5 cac recurrences occurred after stereo tactical catheter implantation and were associated with the following: increased icp, new paresis, coordination imbalance, visual impairment, progressive headaches.Recurrent cacs were treated by cystoperitoneal shunt implantation.- in 1 patient, complication after stereo tactical catheter implantation was the patient developed postoperative bacterial meningitis despite antibiotic prophylaxis.See attached literature article.

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.

• Brand Name: UNKNOWN CATHETER
• 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: 18705769
• MDR Text Key: 335406864
• Report Number: 2021898-2024-00068
• Device Sequence Number: 1
• Product Code: JXG
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• 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): Hospitalization; Required Intervention