DELTA®

Report

Report Number: 9612501-2025-02444
Event Type: Injury
Date Received: September 16, 2025
Date of Event: August 5, 2025
Report Date: September 16, 2025
Manufacturer: MEDTRONIC DOMINICANA
Product Code: JXG
PMA / PMN Number: K902783
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

DANIELA S MASSA. A. CAROLINA OLEA, CARINA O. MAINERI, SANTIAGO A PORTILLO MEDINA. SLIT VENTRICLE COULD BE A NEUROSURGICAL EMERGENCY? CASE REPORT. INTERDISCIPLINARY NEUROSURGERY: ADVANCED TECHNIQUES AND CASE MANAGEMENT. 41 (2025). DOI: 10.1016/J.INAT.2025.102104 A B S T R A C T SYMPTOMATIC SLIT VENTRICLE IS ONE OF COMPLICATIONS OF HYDROCEPHALUS SHUNTING SURGERY IN CHILDREN. IT IS CHARACTERIZED BY THE CLINICAL TRIAD OF HEADACHE, SLOW REFILLING OF THE VALVE AND NARROW VENTRICLES ON IMAGING. WE REPORT THE CASE OF A BOY WITH A VENTRICULOPERITONEAL SHUNT DUE TO PRETERM INTRAVENTRICULAR HEMORRHAGE, AT 22 DAYS OF LIFE. AT AGE OF 33 MONTHS, HE STARTED WITH SYMPTOMS OF SLIT VENTRICLES SYNDROME. HIS PARENTS DID NOT CONSENT TO PERFORMING INVASIVE DIAGNOSTIC METHODS, SO THE BOY ONLY RECEIVED SYMPTOMATIC MEDICATION. AT 40-MONTH-OLD HE HAD ACUTE SEIZURES WITHOUT LOSS OF CONSCIOUSNESS AND AT THAT TIME COMPUTED TOMOGRAPHY (CT) SCAN SHOWED MASSIVE BRAIN EDEMA. AT THAT TIME, AN EMERGENCY FRONTAL BIPARIETAL DECOMPRESSIVE CRANIECTOMY WAS PERFORMED AS AN EMERGENCY PROCEDURE AND AN INTRACRANIAL PRESSURE CATHETER WAS PLACED, WHICH DEMONSTRATED AN INTRACRANIAL PRESSURE OF 40 MMHG. THE ICP CONTINUED TO INCREASE UP TO 100 MMHG WITHOUT RESPONSE TO INTENSIVE MEDICAL TREATMENT AND AFTER 24 HS, A BOY DEVELOPED BRAIN DEATH. INCREASED INTRACRANIAL PRESSURE (ICP) CAN LEAD TO DEATH IN PATIENTS WHO PREVIOUSLY UNDERGONE SHUNT TREATMENT EVEN IN THE ABSENCE OF VENTRICULAR ENLARGEMENT. REPORTED EVENT - WE PRESENT THE CASE OF A PRETERM BOY (34 WEEKS¿ GESTATION AT BIRTH) WHO WAS ADMITTED TO THE NEONATAL INTENSIVE CARE UNIT (NICU) AT 22 DAYS OF LIFE WITH DIAGNOSIS OF INTRAVENTRICULAR HEMORRHAGE GRADE IV WITH HYDROCEPHALUS. HE HAD RECEIVED TREATMENT FOR NEONATAL SEPSIS AND HYALINE MEMBRANE DISEASE IN ANOTHER INSTITUTION. AT ADMISSION, A CT SCAN WAS PERFORMED AND SHOWED ENLARGEMENT OF THE LEFT CHOROID PLEXUS, WITH HEMORRHAGE, AND SUPRA AND INFRATENTORIAL DILATATION OF THE VENTRICULAR SYSTEM WITH ISCHEMIC LESION ON LEFT OCCIPITAL PARENCHYMA. AFTER RESOLUTION OF THE SEPSIS, AN OMMAYA RESERVOIR WITH A VENTRICULAR CATHETER WAS PLACED TO PERFORM PERIODIC PUNCTURES AND WASH THE VENTRICLES TO ELIMINATE CLOTS. DESPITE THIS, THE HYDROCEPHALUS DID NOT RESOLVE, SO AT 32 DAYS OF LIFE AND WEIGHING 3.0 KG, A VENTRICULOPERITONEAL SHUNT (MEDTRONIC DELTA 1.5 PRESSURE) WAS PLACED AND THE OMMAYA CATHETER WAS NOT REMOVED. DURING THE FOLLOWING TWO YEARS, THE PATIENT SHOWED OPTIMAL CLINICAL MANAGEMENT, WITH NORMAL NEURODEVELOPMENTAL MILESTONES AND ABSENCE OF SYMPTOMATIC MANIFESTATIONS. HEAD CIRCUMFERENCE REMAINED WITHIN STANDARD GROWTH PARAMETERS AND THE ANTERIOR FONTANEL CLOSED AT APPROXIMATELY 18 MONTHS OF AGE. THE PATIENT UNDERWENT BIANNUAL CLINICAL AND IMAGING EVALUATIONS TO MONITOR HIS HEALTH STATUS. AFTER THAT PERIOD, HE STARTED WITH EPISODES OF INTERMITTENT VOMITING WITH NAUSEA AND ASTHENIA. CT SCAN WAS NORMAL WITH NARROW VENTRICLES, WHICH WAS CONSIDERED AS A FUNCTIONING SHUNT. THESE SYMPTOMS OCCURRED AT LEAST ONCE A MONTH, CONSEQUENTLY HE WAS EVALUATED FOR GASTROENTEROLOGICAL AND OPHTHALMOLOGICAL ABNORMALITIES WITHOUT ANY FINDING. THROUGHOUT THIS PERIOD, THERE WERE NO VISIBLE ALTERATIONS ON PHYSICAL EXAMINATION OF THE CHILD. THE VALVULAR RESERVOIR SHOWED A COLLAPSIBLE NATURE AND EXHIBITED A SLOW FILLING PATTERN. DURING THIS TIME, MILD HEADACHES WERE TREATED ONLY WITH ANALGESIC THERAPY TO FIND RELIEF AND ANTIEMETIC MEDICATION TO STOP VOMITING EPISODES. SINCE THEY WERE INFREQUENT, THEY DID NOT CAUSE ANY CONCERN TO THE PARENTS AND ONLY BROUGHT HIM FOR REGULAR CHECK-UPS. AT 3 YEARS OF AGE, HE PRESENTED A TONIC CLONIC GENERALIZED SEIZURE, WHICH LED TO THE DECISION TO INITIATE ANTIEPILEPTIC THERAPY. EEG SHOWED AN ORGANIZED, CONTINUOUS AND SYMMETRICAL TRACING WITH THE PRESENCE OF ISOLATED SYNCHRONOUS AND ASYNCHRONOUS BILATERAL FRONTO-CENTRAL SPIKES, AND AN MRI SCAN WAS DONE, WITH NO CHANGES. DURING THE FOLLOWING MONTHS HE CONTINUED WITH THE SAME SYMPTOMS (HEADACHES, NAUSEA AND VOMITING), WHICH BECAME MORE FREQUENT. MULTIPLE OPHTHALMOLOGIC EXAMINATIONS COULD NOT IDENTIFY ANY ABNORMALITIES REGARDING THE FUNDI, AND PAPILLARY EDEMA WAS NEVER REPORTED. EEG SHOWED NO CHANGES, AND NO OTHER COMPLEMENTARY STUDIES WERE PERFORMED. AFTER A MULTIDISCIPLINARY APPROACH, WE PLANNED TO PERFORM A SURGERY TO MONITOR THE ICP AND EVALUATE THE CHANGE OF THE VALVE TO A PROGRAMMABLE ANTISIPHON DEVICE AT SAME MOMENT; HOWEVER, HIS PARENTS DID NOT AGREE WITH THIS STRATEGY AND DECIDED TO WAIT FOR HOW SYMPTOMS GO. OTHER METHODS TO ASSESS ICP WERE NOT ATTEMPTED, DUE TO THE PARENTS¿ REJECTION OF ANY INVASIVE PROCEDURE. IN VIEW OF THE PARENTS¿ CONCERN AND THEIR INITIAL REFUSAL TO AUTHORIZE SURGICAL PROCEDURES, MULTIPLE MEETINGS WERE HELD WITH THE MEDICAL TEAM, WITH THE AIM THAT THE MULTIDI SCIPLINARY APPROACH WOULD CONTRIBUTE TO PROVIDE SUPPORT AND FACILITATE DECISION MAKING. FINALLY, AT 3 AND A HALF YEARS OF AGE, THE PATIENT WAS READMITTED TO THE PEDIATRIC EMERGENCY UNIT DUE TO PERSISTENT FREQUENT VOMITING AND A PROGRESSIVE INCREASE IN ASTHENIA. A COMPUTED TOMOGRAPHY SCAN REVEALED NARROWED VENTRICLES WITHOUT SIGNIFICANT CHANGES, AND OPHTHALMOLOGIC EXAMINATION SHOWED NO SIGNS OF INTRACRANIAL HYPERTENSION. IN VIEW OF THE CLINICAL EVOLUTION, THE NEED FOR SURGICAL INTERVENTION WAS AGAIN INSISTED UPON. ON THIS OCCASION, THE PARENTS GAVE THEIR CONSENT, EXPRESSING GREATER CONFIDENCE IN THE DECISION, AND THE PROCEDURE WAS SCHEDULED FOR THE FOLLOWING DAY. DURING THE NIGHT, THE BOY STARTED VOMITING (AS USUAL) AND PRESENTED SEIZURES THAT INITIALLY RESPONDED TO BENZODIAZEPINES. BUT THEN TONIC CLONIC SEIZURES APPEARED AGAIN AND BECAME AN EPILEPTIC STATUS; SO, IT WAS DECIDED TO ADMINISTER GENERAL SEDATION AND PUT HIM ON MECHANICAL VENTILATORY ASSISTANCE. A CT SCAN WAS PERFORMED THAT SHOWED A DIFFUSE BRAIN EDEMA WITH SMALL VENTRICLES. AT THAT TIME, LABORATORY FINDINGS WERE ULTRASENSITIVE C-REACTIVE PROTEIN 0.70 MG/L; SERUM SODIUM 131.9 MMOL/L; SERUM POTASSIUM 3.3 MMOL/L; SERUM CHLORIDE 106 MMOL/L; SERUM MAGNESIUM 1.7 MG/DL; FIBRINOGEN 278 MG/DL; HEMOGLOBIN 10.5 G/DL; HEMATOCRIT 29.8 %; RED BLOOD CELL COUNT 3.86 MILLION/ MM3; LEUKOCYTE COUNT 9. 752/MM3; SEGMENTED NEUTROPHILS 90.65 %; BASOPHILS 0.16 %; LYMPHOCYTES 5.31 %; MONOCYTES 3.88 %; PLATELET COUNT 339. 500/MM3; APTT 25 S; PH 7.386; PCO2 28.7 MMHG; BASE EXCESS - 7.0 MMOL/L; BICARBONATE 16.8 MMOL/L; O XYHEMOGLOBIN 98.3 %; BLOOD LACTATE 4.09 MMOL/L; PO2 185.4 MMHG; IONIC CALCIUM 1.19 MMOL/L; TOTAL CALCIUM 9.9 MG/DL; PHOSPHORUS 3.4 MG/DL; CREATININE 0.24 MG/DL; AND GLUCOSE 163 MG/DL. A FUNDUS SHOWED PAPILLEDEMA BILATERALLY, SO WE DECIDED TO PERFORM AN URGENT BILATERAL CRANIECTOMY AND PLACE AN INTRACRANIAL PRESSURE (ICP) MEASURE CATHETER (NATUS, CAMINO ®). SUBSEQUENTLY, AN AUTOLOGOUS FLAP DUROPLASTY WAS PERFORMED AND THE BONE WAS NOT REPOSITIONED. IN THE SAME SURGICAL PROCEDURE, THE SHUNT WAS REVISED AND SHOWED ADEQUATE FUNCTION, SO IT WAS DISCONNECTED, AND THE PROXIMAL CATHETER WAS CONNECTED TO AN EXTERNAL VENTRICULAR DRAINAGE RESERVOIR. ICP WAS 40 MMHG AND THE BRAIN TISSUE WAS PALE WITHOUT ADEQUATE BEAT. THE CHILD WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU) AND DESPITE INTENSIVE MEDICAL TREATMENT CONSISTING OF HYPERTONIC SOLUTIONS, MANNITOL, VENTILATION AT NORMAL OR SLIGHTLY LOW PACO2, ANTICONVULSANTS, ANALGESICS, INTRAVENOUS SEDATIVES AND TEMPERATURE CONTROL; ICP CONTINUED TO RISE TO 100 MMHG AND THE PATIENT EVOLVED IN THE FOLLOWING 24 H WITHOUT SPONTANEOUS OCULAR OPENING, PUPILS MYDRIATIC, BILATERAL HYPOREACTIVE, NO SPONTANEOUS MOVEMENTS, GENERALIZED FLACCID HYPOTONIA, LOCALIZES AND RETRACTS TO PAINFUL STIMULUS IN LOWER AND UPPER LIMBS, SYMMETRICAL OSTEOTENDINOUS REFLEXES: BICIPITAL 2/4, PATELLAR AND ACHILLES 1/4, NO CLONUS OR BABINSKI, NEGATIVE BILATERAL CORNEAL REFLEX, NEGATIVE BILATERAL OCULOCEPHALIC REFLEXES, NEGATIVE BILATERAL VESTIBULOOCULAR REFLEXES, NEGATIVE COUGH REFLEX. 48 H LATER HE WAS DIAGNOSED AS BRAIN DEAD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2681339	DELTA®	SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS	JXG	MEDTRONIC DOMINICANA	UNKNOWN-A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	3 YR	Male	Required Intervention