MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2018-04-04 for UNKNOWN NEUROENDOSCOPE UNKNOWN-ES manufactured by Medtronic Neurosurgery.
[104402328]
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. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[104402329]
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. 3 patients developed meningitis, 1 in the context of a cerebrospinal fluid (csf) leak. 2 of the infections occurred within 2 weeks following etv/cpc and both required subsequent ventriculoperitoneal shunt (vps) placement. In the third case, meningitis occurred after vps placed 2 weeks after etv/cpc. The vps infection was treated with vps removal, csf reservoir placement, and serial csf aspirations; however, the patient developed a cerebral abscess requiring surgical evacuation. This patient died 2 months postoperatively. This complication occurred in the first half of the study period which was before may 2010. There were 2 deaths which occurred at 8 and 26 months after surgery. One of the mortalities occurred 21 months after a ventriculoperitoneal shunt (vps) was placed for etv/cpc failure. The other mortality was a newborn with hydranencephaly who died of cardiorespiratory arrest 8 months after etv/cpc.
Patient Sequence No: 1, Text Type: D, B5
[106892899]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[106892900]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00181 |
| MDR Report Key | 7397943 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-04-04 |
| Date of Report | 2018-04-30 |
| Date of Event | 2015-10-30 |
| Date Mfgr Received | 2018-04-27 |
| Date Added to Maude | 2018-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN NEUROENDOSCOPE |
| Generic Name | ENDOSCOPE, NEUROLOGICAL |
| Product Code | GWG |
| Date Received | 2018-04-04 |
| Model Number | UNKNOWN-ES |
| Catalog Number | UNKNOWN-ES |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2018-04-04 |