MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-V

Device Problem Complete Blockage (1094)

Patient Problem Bacterial Infection (1735)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Marcelo galarza & volkan etus & fidel sosa & romina argañaraz &beatriz mantese & roberto gazzeri & christian garcia montoya & pedro de la rosa & antonio lópez guerrero & gerald chaban & ángel giménez & josé maría amigó.Flow ventricular catheters for shunted hydrocephalus: initial clinical results.Child's nervous system (2020).Doi: 10.1007/s00381-020-04941-8 abstract background the non-homogenous flow of the cerebrospinal fluid within the ventricular catheter is one of the causative factors in shunt obstructions during the treatment of hydrocephalus.Previously, we studied the flow in ventricular catheters under the steady and pulsatile boundary conditions by means of computational fluid dynamics (cfd) in three-dimensional paradigms.Subsequently, several catheter designs with homogeneous flow patterns were developed out of which one prototype was chosen after a validation study.Objective to test the effectiveness of the flow ventricular catheter in a prospective, multicenter, comparative study.Methods eligible centers were three pediatric hospitals: two with sole adult practice and one a mixed pediatric-adult.Standard silicone material was used to develop a parametric cathetermodel with homogenous flow characteristics.The flow catheters were inserted in pediatric (n = 30) and adult (n = 10) patients with all types of hydrocephalus.Simultaneously, regular ventricular catheters were inserted in another 43 control patients in the participating centers.Catheter positioning was standardized according to the schaumann and thomale classification.Results all ventricular catheters had a cephalad grade i or ii positioning, and caudally, its extension had a peritoneal location.Programmable valves were utilized in 70% and antisiphon devices in 20% of the cases.Regular differential pressure valves were utilized in the remaining.No case of flow catheter obstruction was identified during a mean follow-up period of 2 years at the time of this writing.There were four catheter obstructions in the control cohort, all pediatric cases, during the first year.Shunt infections occurred in two cases in the control group, while there was one recurrent case of adult ventriculitis in the flow catheter group.Conclusions this prototype model represents the next generation of ventricular catheters with a homogeneous flow pattern.The flow catheter can be inserted safely in hydrocephalic patients, and this preliminary prospective comparative study showed a possible obstruction-free functionality.Reported events - in the control group, shunt infections, with klebsiella sp.And staphylococcus aureus respectively, occurred in two cases: one neonate and one adult with nph.Both cases were then treated accordingly with antibiotics, shunt removal, evd insertion and subsequent shunt revision after negative csf cultures.- one patient with posthemorrhagic hydrocephalus (sah) was implanted with a vp shunt the flow catheter.Subsequently, this patient developed fever spikes after 10 days and new csf cultures revealed persistence of the stenotrophomonas infection, and the entire shunt system, although functioning, was removed.After adequate antibiotic therapy confirmed by negative csf cultures, a new vp shunt system was inserted, this time with the standard ventricular catheter.This patient was later discharged home with family support and her latest imaging showed a controlled hydrocephalus.- in the control group, the ventricular catheter obstruction in the vp shunt system occurred in four pediatric cases.The shunt malfunctions occurred during the first year after surgery and were diagnosed by clinical and imaging signs of ventriculardilatation.In cases with obstructed ventricular catheter, all with occipital entry point and schaumann and thomale type i grade, the etiologies of the hydrocephalus included prematurity and congenital hydrocephalus.The obstruction of the vc happened between 4 and 6 months after insertion in two premature infants and, 12 to 14 months after insertion, in two cases with congenital hydrocephalus.All these patients required operative revision of the vp shunt system with replacement of the ventricular catheter.Thereafter, no further malfunctions of the vp shunt system were recorded.

• Brand Name: UNKNOWN VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 11232974
• MDR Text Key: 229118556
• Report Number: 2021898-2021-00026
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention