MEDTRONIC NAVIGATION
Report
- Report Number
- 1723170-2019-01138
- Event Type
- Injury
- Date Received
- March 20, 2019
- Date of Event
- November 15, 2018
- Report Date
- March 19, 2019
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- HAW
- PMA / PMN Number
- K050438
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- PHYSICIAN
Narratives
PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM NAME AND SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. JOURNAL ARTICLE INDICATED USE OF STEALTHSTATION PLANNING SOFTWARE. UDI NOT AVAILABLE FOR THIS SYSTEM. FACILITY IS NOT PROVIDED ARTICLE. CORRESPONDING AUTHOR IS LISTED AT THE UNIVERSITY OF ALABAMA AT BIRMINGHAM, DEPARTMENT OF PEDIATRICS, DIVISION OF PEDIATRIC HEMATOLOGY-ONCOLOGY AND DEPARTMENT OF NEUROSURGERY, DIVISION OF PEDIATRIC NEUROSURGERY. PROCODE PROVIDED IS FOR MOST COMMON NAVIGATION SYSTEM. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
CITATION: JOSHUA D. BERNSTOCK, ZACHARY WRIGHT, ASIM K. BAG, FLORIAN GESSLER, GEORGE YANCEY GILLESPIE, JAMES M. MARKERT, GREGORY K. FRIEDMAN, JAMES M. JOHNSTON, STEREOTACTIC PLACEMENT OF INTRATUMORAL CATHETERS FOR CONTINUOUS INFUSION DELIVERY OF HERPES SIMPLEX VIRUS -1 G207 IN PEDIATRIC MALIGNANT SUPRATENTORIAL BRAIN TUMORS, WORLD NEUROSURGERY, VOLUME 122, 2019, PAGES E1592-E1598, ISSN 1878-8750, HTTPS: //DOI.ORG/10.1016/J.WNEU.2018.11.122. SUMMARY: OBJECTIVE: THE ENGINEERED HERPES SIMPLEX VIRUS-1 G207, IS A PROMISING THERAPEUTIC OPTION FOR CENTRAL NERVOUS SYSTEM TUMORS. THE FIRST-EVER PEDIATRIC PHASE 1 TRIAL OF CONTINUOUS-INFUSION DELIVERY OF G207 VIA INTRATUMORAL CATHETERS FOR RECURRENT OR PROGRESSIVE MALIGNANT BRAIN TUMORS IS ONGOING. IN THIS ARTICLE, WE DESCRIBE SURGICAL TECHNIQUES FOR THE ACCURATE PLACEMENT OF CATHETERS IN MULTIPLE SUPRATENTORIAL LOCATIONS AND PERIOPERATIVE COMPLICATIONS ASSOCIATED WITH SUCH PROCEDURES. METHODS: A PROSPECTIVE STUDY OF G207 IN CHILDREN WITH RECURRENT MALIGNANT SUPRATENTORIAL TUMORS IS ONGOING. PREOPERATIVE STEREOTACTIC PROTOCOL MAGNETIC RESONANCE IMAGING WAS PERFORMED, AND CATHETER TRAJECTORIES PLANNED USING STEALTHSTATION PLANNING SOFTWARE. CHILDREN UNDERWENT PLACEMENT OF 3E4 SILASTIC CATHETERS USING A SMALL INCISION BURR HOLE AND THE VERTEK SYSTEM. PATIENTS HAD A PREINFUSION COMPUTED TOMOGRAPHY SCAN TO CONFIRM CORRECT PLACEMENT OF CATHETERS. RESULTS: SIX CHILDREN UNDERWENT IMPLANTATION OF 3E4 CATHETERS. LOCATIONS OF CATHETER PLACEMENT INCLUDED FRONTAL, TEMPORAL, PARIETAL, AND OCCIPITAL LOBES, AND THE INSULA AND THALAMUS. THERE WERE NO CLINICALLY SIGNIFICANT PERIOPERATIVE COMPLICATIONS. POSTOPERATIVE COMPUTED TOMOGRAPHY SCANS COUPLED WITH PREOPERATIVE MRI SCANS DEMONSTRATED ACCURATE PLACEMENT OF 21 OF 22 CATHETERS, WITH 1 MISPLACED CATHETER PULLED BACK TO AN OPTIMAL LOCATION AT THE BEDSIDE. ONE PATIENT HAD HEMORRHAGE ALONG THE CATHETER TRACT THAT WAS CLINICALLY ASYMPTOMATIC. ANOTHER PATIENT HAD CEREBROSPINAL FLUID LEAK FROM A BIOPSY INCISION 9 DAYS AFTER SURGERY THAT WAS OVERSEWN WITHOUT COMPLICATION. CONCLUSIONS: THE PLACEMENT OF MULTIPLE INTRATUMORAL CATHETERS IN PEDIATRIC PATIENTS WITH SUPRATENTORIAL TUMORS VIA FRAMELESS STEREOTACTIC TECHNIQUES IS FEASIBLE AND SAFE. INTRATUMORAL CATHETERS PROVIDE A POTENTIALLY EFFECTIVE ROUTE FOR THE DELIVERY OF G207 AND MAY BE EMPLOYED IN OTHER TRIALS UTILIZING ONCOLYTIC VIROTHERAPY FOR BRAIN TUMORS. REPORTED EVENTS: ONE ELEVEN-YEAR-OLD MALE WITH GLIOBLASTOMA IN THE LEFT FRONTAL REQUIRED REVISION OF ONE CATHETER THAT WAS IN A TUMOR WITHIN THE CORPUS CALLOSUM, BUT 2 MM FROM THE VENTRICLE. GIVEN THE PROXIMITY TO THE VENTRICLE AND CEREBROSPINAL FLUID (CSF), THE CATHETER WAS WITHDRAWN 1.5 CM AT THE BEDSIDE INTO THE MAIN BODY OF THE TUMOR. THE PATIENT EXPERIENCED A DELAYED CSF LEAK FROM THE INITIAL BIOPSY AND CATHETER PLACEMENT SITE. HE PRESENTED TO THE EMERGENCY DEPARTMENT 9 DAYS AFTER THE BIOPSY AND PLACEMENT OF THE CATHETERS WITH CLEAR FLUID DRAINAGE FROM THE SURGICAL SITE, FEVER TO 101 DEGREES FAHRENHEIT, AND NO OTHER COMPLAINTS. HIS NEUROLOGIC EXAM WAS UNREMARKABLE. THE LEAK WAS OVERSEEN SUCCESSFULLY AT THE BEDSIDE. HIS WHITE BLOOD CELL COUNT WAS ELEVATED AT 13.7 X 103/ML (NORMAL RANGE 3.8-9.8 X 103/ML) WITH A NORMAL DIFFERENTIAL. A LUMBAR PUNCTURE WAS PERFORMED TO RULE OUT MENINGITIS AND THE OPENING PRESSURE WAS>50 CM H20, WITH 20 ML OF CSF REMOVED TO DECREASE PRESSURES AND FOR CYTOLOGY. HE WAS ADMITTED FOR EVALUATION AND HAD NO ADDITIONAL FEVER, SIGNS OR SYMPTOMS OF MENINGITIS, OR HSV ENCEPHALITIS.CSF BACTERIAL CULTURES WERE NEGATIVE AND HSV VIRAL POLYMERASE CHAIN REACTION LEVEL WAS FOUND TO BE 5480 COPIES/ML (3.7 LOG COPIES/ML), CONSISTENT WITH RESIDUAL G207 VIRUS FROM THE INFUSION (1 X 108 PLAQUEFORMING UNITS) 8 DAYS PRIOR. HE WAS DISCHARGED AFTER BACTERIAL INFECTION WAS RULED OUT WITH NO FURTHER LEAK. OPHTHALMOLOGIC EVALUATION DEMONSTRATED NO PAPILLEDEMA. ONE THIRTEEN-YEAR-OLD MALE WITH GLIOBLASTOMA IN THE MESIAL OCCIPITAL, POSTERIOR TEMPORAL HAD A TRACT HEMORRHAGE NOTED ON POSTOPERATIVE CT SCAN. THIS HEMORRHAGE DID NOT INCLUDE THE CATHETER TIP, DID NOT CAUSE NEUROLOGIC SEQUELAE, AND WAS STABLE ON FOLLOW-UP MRI SCAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 230010 | MEDTRONIC NAVIGATION | INSTRUMENT, STEREOTAXIC | HAW | MEDTRONIC NAVIGATION, INC | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Hospitalization| R |