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

Model Number UNKNOWN-V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Seroma (2069); Therapeutic Effects, Unexpected (2099); Vomiting (2144)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Event date: please note that this date is based off the date of publication of the article as the actual event date was not provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Hc ludwig <(>&<)> m reitemeyer <(>&<)> hc bock <(>&<)> m sigler.Hydrocephalus shunt therapy: current titanium shunt valve implants obstructed by internal tissue proliferations identified as extracellular matrix membranes.Child's nervous system (2019).Doi: 10.1 007/s00381-019-04467-8.Abstract purpose shunt valves, required for treatment of hydrocephalus, demand for high performance rates and lifelong excellent function.To overcome problems with traditional silicone materials, adjustable and gravity-adapted titanium valves were developed.Even modern shunt valve systems are still subject to occlusion.The aim of the present study was to investigate dysfunctional silicone and titanium valves for presence of cellular and proteinous materials inside the housings by means of histopathology.Methods a total of 19 explanted shunt valves from children between 2 and 182 months of age were investigated following dysfunction.After fixation in formalin and embedding in hard resin, slices were ground to a thickness of 5¿30.Besides standard histology, immunohistochemistry was performed using antibodies with markers for microglia, astrocytes, platelets, monocytes, and the proteins laminin, fibronectin, and collagen iv.Results traces, layers, and plaques could be demonstrated in every investigated silicone or titanium valve with an implantation time of more than 6 days.Most of the tissue was found adjacent to silicone and titanium surfaces of the inner housing, the a djustment rotor, and ball-in-cone core.Markers for micro and astroglia stained positive in 40¿60% of the specimen, mostly demonstrating a proteinous layer positive for laminin (80%), fibronectin (30%), and collagen iv (30%).Conclusions tissue reactions with form ation of cellular and proteinous matrix components are common in obstructed silicone and titaniumshunt valves.The tissue mimics astrocytic repair mechanisms genuine for basilar membranematrix.The knowledge of these typical arachnoid patterns ofcolonization is a prerequisite for developing future shunt devices.Reported event.A patient's valve was explanted due to occlusion.The main symptoms were elevated head circumference, headache, and vomiting, and/or documentation of subgaleal csf collections.

• Brand Name: UNKNOWN VALVE/SHUNT
• 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9603580
• MDR Text Key: 189990115
• Report Number: 2021898-2020-00018
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• 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: 01/13/2020
• 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: 15 YR