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 2018-02-03 for UNKNOWN NEUROENDOSCOPE UNKNOWN-ES manufactured by Medtronic Neurosurgery.
[98967867]
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. The source literature included the following device specifics: a rigid neuroendoscope was used in all cases (clarus). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[98967868]
Aria fallah, md, msc, frcsc, alexander g. Weil, md, frcsc, kyle juraschka, md, george m. Ibrahim, md, phd, anthony c. Wang, md, louis crevier, md, msc, frcsc, chi-hong tseng, phd, abhaya v. Kulkarni, md, phd, frcsc, john ragheb, md, and sanjiv bhatia, md. The importance of extent of choroid plexus cauterization in addition to endoscopic third ventriculostomy for infantile hydrocephalus: a retrospective north american observational study using propensity score? Adjusted analysis. J neurosurg pediatrics. Doi: 10. 3171/2017. 7. Peds16379. Abstract: objective: combined endoscopic third ventriculostomy (etc) and choroid plexus cauterization (cpc)? Etv/cpc? Is being investigated to increase the rate of shunt independence in infants with hydrocephalus. The degree of cpc necessary to achieve improved rates of shunt independence is currently unknown. Methods: using data from a single-center, retrospective, observational cohort study involving patients who underwent etv/cpc for treatment of infantile hydrocephalus, comparative statistical analyses were performed to detect a difference in need for subsequent csf diversion procedure in patients undergoing partial cpc (describes unilateral cpc or bilateral cpc that only extended from the foramen of monro [fm] to the atrium on one side) or subtotal cpc (describes cpc extending from the fm to the posterior temporal horn bilaterally) using a rigid neuroendoscope. Propensity scores for extent of cpc were calculated using age and etiology. Propensity scores were used to perform case-matching comparisons and cox multivariable regression, adjusting for propensity score in the unmatched cohort. Cox multivariable regression adjusting for age and etiology, but not propensity score was also performed as a third statistical technique. Results: eighty-four patients who underwent etv/cpc had sufficient data to be included in the analysis. Subtotal cpc was performed in 58 patients (69%) and partial cpc in 26 (31%). The etv/cpc success rates at 6 and 12 months, respectively, were 49% and 41% for patients undergoing subtotal cpc and 35% and 31% for those undergoing partial cpc. Cox multivariate regression in a 48-patient cohort case-matched by propensity score demonstrated no added effect of increased extent of cpc on etv/cpc survival (hr 0. 868, 95% ci 0. 422? 1. 789, p = 0. 702). Cox multivariate regression including all patients, with adjustment for propensity score, demonstrated no effect of extent of cpc on etv/ cpc survival (hr 0. 845, 95% ci 0. 462? 1. 548, p = 0. 586). Cox multivariate regression including all patients, with adjustment for age and etiology, but not propensity score , demonstrated no effect of extent of cpc on etv/cpc survival (hr 0. 908, 95% ci 0. 495? 1. 664, p = 0. 755). Conclusions: using multiple comparative statistical analyses, no difference in need for subsequent csf diversion procedure was detected between patients in this cohort who underwent partial versus subtotal cpc. Further investigation regarding whether there is truly no difference between partial versus subtotal extent of cpc in larger patient populations and whether further gain in cpc success can be achieved with complete cpc is warranted. Reported events: the median time to repeat csf diversion procedure was 3. 0? 1. 1 and 3. 0? 3. 0 months for the cohorts that underwent partial and subtotal cpc, respectively (log-rank [mantel-cox] test, p = 0. 674).
Patient Sequence No: 1, Text Type: D, B5
[103783921]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[103783922]
Additional information received reported that only a small proportion of these cases were done with the manufacturer's channel scope; however, no data was collected as part of the project. It was also stated that no adverse events or complications in the cohort were at all the consequence of the scope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2018-00058 |
| MDR Report Key | 7239865 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-02-03 |
| Date of Report | 2018-03-28 |
| Date of Event | 2017-10-06 |
| Date Mfgr Received | 2018-03-21 |
| Date Added to Maude | 2018-02-03 |
| 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 | 2018-02-03 |
| Model Number | UNKNOWN-ES |
| Catalog Number | UNKNOWN-ES |
| Lot Number | UNKNOWN |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-02-03 |