MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN NEUROENDOSCOPE; ENDOSCOPE, NEUROLOGICAL

Model Number UNKNOWN-ES

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

Patient Problems Hemorrhage, Cerebral (1889); Seroma (2069); Therapeutic Effects, Unexpected (2099)

Event Date 10/30/2015

Event Type  Injury  

Manufacturer Narrative

Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided.Please note that this date is based off the date of publication of the article as the actual event date was not provided.[(b)(4)].

Event Description

Alexander g.Weil, md , frcsc , aria fallah, md , ms c, frcsc , parthasarathi chamiraju, md , john ragheb, md , and sanjiv bhatia, md.Endoscopic third ventriculostomy and choroid plexus cauterization with a rigid neuroendoscope in infants with hydrocephalus.Journal of neurosurgery pediatrics 17 (2016).Doi: 10.3171/2015.5.Peds14692 objective combining endoscopic third ventriculostomy (etv) with choroid plexus cauterization (cpc) has been shown to improve the success rate compared with etv alone in infants (less than 24 months) with hydrocephalus who were treated in developing countries.The authors sought to evaluate the safety and efficacy of this procedure, using a rigid neuroendoscope, in a single north american center, and to assess whether the etv success score (etvss), the cure children¿s hospital of uganda etvss (cchu etvss), and other pre- and intraoperative variables could predict success.Methods the authors performed a retrospective review of consecutive etv/cpc procedures performed using a rigid neuroendoscope to treat infantile hydrocephalus.The infants underwent the procedure at miami children¿s hospital between january 2007 and 2014, with at least one postoperative follow-up.Duration of follow-up or time to failure of etv/cpc, the primary outcome measure, was documented.A repeat csf diversion procedure or death was considered as a failure of etv/cpc.The time to event was measured using a kaplan-meier analysis.The authors analyzed etvss, cchu etvss, and pre- and intraoperative variables to determine their suitability to predict success.Results eighty-five patients (45 boys) with a mean age of 4.3 months (range 1 day to 20 months) underwent etv/cpc.Etiology included intraventricular hemorrhage of prematurity in 44 patients (51.7%), my elomeningocele (mmc) in 7 (8.2%), congenital aqueductal stenosis in 12 (14.1%), congenital communicating hydrocephalus in 6 (7.1%), dandy-walker complex in 6 (7.1%), postinfectious hydrocephalus in 5 (5.8%), and other cause in 5 (5.8%).Six procedure-related complications occurred in 5 (5.8%) patients, including 2 hygromas, 1 csf leak, and 3 infections.There were 3 mortalities in this cohort.Etv/cpc was successful in 42.1%, 37.7%, and 36.8% of patients at 6, 12, and 24 months follow-up, respectively.The median (95% ci) time to etv/cpc failure was 4.0 months (0.9¿7.1 months).In univariate analyses, both the etvss (hazard ratio [hr] 1.03; 95% ci 1.01¿1.05; p = 0.004) and cchu etvss (hr 1.48; 95% ci 1.04¿2.09; p =.028) were predictive of outcome following etv/cpc.In multivariate analysis, the presence of prepontine scarring was associated with etv/cpc failure (hr 0.34; 95% ci 0.19¿0.63; p <(><<)> 0.001).Other variables, such as radiological criteria (prepontine interval, prepontine space, aqueductal stenosis, third ventricular morphology index) and intraoperative findings (ventriculostomy pulsations, extent of cpc), did not predict outcome.Conclusions etv/cpc is a feasible alternative to etv and ventriculoperitoneal shunt in infants with hydrocephalus.Both the etvss and cchu etvss predicted success following etv/cpc in this single-center north american cohort of patients.Reported events.Intraoperative hemorrhage was minimal in 13 patients and moderate in 2 patients.Etv/cpc was unsuccessful in 57.9%, 62.3%, and 63.2% of patients at 6, 12, and 24 months of follow-up, respectively.Two patients developed subdural hygromas, one of which was symptomatic requiring aspiration.This complication occurred in the first half of the study period which was before may 2010.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that the outcomes of the study, complications were not related to any device malfunction.In some cases, the channel neuroendoscopes were used to execute the procedure, but the complications were not related to the device.

• Brand Name: UNKNOWN NEUROENDOSCOPE
• Type of Device: ENDOSCOPE, NEUROLOGICAL
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7397922
• MDR Text Key: 104404848
• Report Number: 2021898-2018-00180
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-ES
• Device Catalogue Number: UNKNOWN-ES
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 4 MO