MAUDE Adverse Event Report: COVIDIEN LLC STRATA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-S

Device Problems Complete Blockage (1094); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Vomiting (2144)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Ludwig, h.C, reitemeyer, m., bock, h.C, sigler, m.Hydrocephalus shunt therapy: current titanium shunt valve implants obstructed by internal tissue proliferations identified as extracellular matrix membranes.Child's nervous system (2020) 36:2717¿2724.Https://doi.Org/10.1007/s00381-019-04467-8.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 adjustment 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 formation of cellular and proteinous matrix components are common in obstructed silicone and titanium shunt valves.The tissue mimics astrocytic repair mechanisms genuine for basilar membrane matrix.The knowledge of these typical arachnoid patterns of colonization is a prerequisite for developing future shunt devices.Reported events: the 10 valves had to be removed due to valve obstructions 1 valve was removed due to being defective.3 cases of infection with revisions 11 explanations were caused by occlusion or underdrainage in the case of partial occlusion independent from the proximal catheter.Headache and vomiting, and/or documentation of subgaleal cerebrospinal fluid (csf) collections.

• Brand Name: STRATA®
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14193935
• MDR Text Key: 290086957
• Report Number: 9612501-2022-00638
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other