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

Model Number UNKNOWN-S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: unknown-a, serial/lot #: unknown.Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided.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

Joyce koueik, mark r.Kraemer, david hsu, elias rizk, ryan zea, clayton haldeman, and bermans j.Iskandar.A 12-year single-center retrospective analysis of antisiphon devices to prevent proximal ventricular shunt obstruction for hydrocephalus.Journal of neurosurgery pediatrics (2019).Doi: 10.3171/2019.6.Peds1951.Objective recent evidence points to gravity-dependent chronic shunt overdrainage as a significant, if not leading, cause of proximal shunt failure.Yet, shunt overdrainage or siphoning persists despite innovations in valve technology.The authors examined the effectiveness of adding resistance to flow in shunt systems via antisiphon devices (asds) in preventing proximal shunt obstruction.Methods a retrospective observational cohort study was completed on patients who had an asd (or additional valve) added to their shunt system between 2004 and 2016.Detailed clinical, radiographic, and surgical findings were examined.Shunt failure rates were compared before and after asd addition.Results seventy-eight patients with shunted hydrocephalus were treated with placement of an asd several centimeters distal to the primary valve.The records of 12 of these patients were analyzed separately due to a complex shunt revision history (i.E., > 10 lifetime shunt revisions).The authors found that adding an asd decreased the 1-year ventricular catheter obstruction rates in the ¿simple¿ and ¿complex¿ groups by 67.3% and 75.8%, respectively, and the 5-year rates by 43.3% and 65.6%, r espectively.The main long-term asd complication was asd removal for presumed valve pressure intolerance in 5 patients.Conclusions using an asd may result in significant reductions in ventricular catheter shunt obstruction rates.If confirmed with prospective studies, this observation would lend further evidence that chronic shunt overdrainage is a central cause of shunt malfunction, and provide pilot data to establish clinical and laboratory studies that assess optimal asd type, number, and position, and eventually develop shunt valve systems that are altogether resistant to siphoning reported events.- asds were inserted in the shunt system for recurrent ventricular catheter obstructions in 45 patients (57.7%) and for overdrainage -related symptoms in 33 patients (42.3%).Forty-seven patients (60.2%) had a shunt revision for malfunction at the time of asd placement.Of these, 23 (48.9%) had a new ventricular catheter inserted due to proximal obstruction (3 of whom had concomitant replacement of the primary valve), 13 (27.6%) had a distal catheter revision, 6 (12.8%) had a new shunt system inserted after a shunt infection, and 5 (10.6%) had a shunt system reinstated after failed etv.Of the 78 patients in this literature article, 18 of the patients were identified to have the manufacturer's device as a primary valve(9 strata and 9 delta), but it is unclear whether the shunt malfunctions and revisions were involved with the 18 patients that had the manufacturer's device.See attached literature article.

• Brand Name: UNKNOWN STRATA 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 ; 7635263305
• MDR Report Key: 9317258
• MDR Text Key: 166495528
• Report Number: 2021898-2019-00409
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• 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