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

Model Number UNKNOWN-C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Neurological Deficit/Dysfunction (1982); Paresis (1998); Vomiting (2144); Loss of consciousness (2418)

Event Date 05/16/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Drosos evangelos, giakoumettis dimitrios, sfakianos georgios, eleftherakis nikolaos, papadopoulos filippos, themistocleous marios.P ercutaneous placement of the peripheral catheter to the subclavian vein for a va shunt.The pan african medical journal 27 (2017).Doi:10.11604/pamj.2017.27.42.11374 abstract hydrocephalus is a common neurosurgical pathology that affects people of all ages and especially the pediatric population.It can be very often a life threatening condition that pediatric neurosurgeons must deal with.Therefore a number of csf diversion techniques have been established.The gold standard treatment currently is the placement of a ventriculo-peritoneal shunt.Because of hydrocephalus being a lifelong condition, it is almost in daily practice dealing with cases of shunt failures for a number of reasons.Herewith we present a (b)(6) year old child with multiple ventriculo-peritoneal shunt revision surgeries and ventriculo-atrial failure due to distal catheter malfunction that was treated with percutaneous placement of the peripheral catheter in the subclavian vein.Reported event.A (b)(6) year-old boy presented in the emergency department with hydrocephalus due to ventriculo-peritoneal shunt malfunction and because of no alternatives he was treated with a ventriculo-atrial (va) shunt which was percutaneously inserted through the subclavian vein.The child had been diagnosed at the age of two months with an intramedullary spinal cord tumor with pathology of primitive neuroec todermal tumor (pnet) grade iv according to world health organization.At first he presented with left hemiparesis and underwent brain and spinal mri that revealed hydrocephalus and a 4.7 × 1.5 cm intramedullary lesion extending from the second cervical to the first thoracic vertebrae.Furthermore there was a leptomeningeal spread not only intracranially but in the spinal canal as well.The patient underwent two operation procedures.Firstly, a ventriculo-peritoneal shunt (medtronic ps medical) was placed to deal with hydrocephalus and then a radical resection of the tumor was performed; nevertheless, some small tumor remnants were left behind because they could not be safely removed.The postoperative period was complicated with prolonged stay in the pediatric intensive care unit due to postoperative neurological deterioration.During his stay in the icu, the patient experienced an episode of cardiac arrest and a permanent internal defibrillator was implanted through the right subclavian vein.Finally he was discharged from the neurosurgical department with severe left hemiparesis and he was further treated with high-dose chemotherapy.In the following years he underwent four revision surgeries, which included several revisions of the distal part and the introduction of a new proximal catheter at t he opposite lateral ventricle, due to vp malfunction caused by peritoneal malabsorption.In the last operation, the distal catheter was implanted to the right internal jugular vein.At the age of (b)(6) years old the child presented to the emergency department with deteriorating level of consciousness and vomiting.The shunt was tapped and demonstrated increased pressure with good proximal flow and absence of distal runoff.A computer tomography (ct) scan revealed ventricles dilatation and periventricular edema figure 1.Moreover an ultrasound imaging of the neck veins revealed bilateral internal jugular vein thrombosis.Due to lack of alternative solutions, a decision was made to implant the distal catheter in the right atrium through the left subclavian vein with the help of the interventional cardiologist of the hospital.The patient made an uneventful recovery with no post-operative complications and he was discharged free of symptoms of increased intracranial pressure a few days later.At one year follow-up the child is without symptoms of hydrocephalus and the ct scan shows a normal ventricular system with both catheters in place.

• Brand Name: UNKNOWN CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8486739
• MDR Text Key: 141032901
• Report Number: 2021898-2019-00139
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• 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
• Patient Age: 4 YR