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

Model Number UNKNOWN-V

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930)

Event Date 09/07/2021

Event Type  Injury  

Event Description

Youngbo shim, kyung hyun kim, ji yeoun lee, seung-ki kim, ji hoon phi.The stability of multifocal ventriculoperitoneal shunts with y-connections.Child's nervous system 37 (2021).Doi: 10.1007/s00381-021-05349-8 abstract purpose multifocal ventriculoperitoneal shunts with y-connections (mvps with ys) are widely used in many centers when neuroendoscopic procedures on entrapped ventricles are not feasible; however, their use is not frequent.This study aimed to confirm the stability of an mvps with y and, for the first time, identify the factors that influence stability.Methods we studied 33 consecutive patients who underwent initial conversion tomvps with ys.The one-year overall shunt survival rate was calculated and compared with the historical outcome of single ventriculoperitoneal shunts (vpss).The factors influencing the one-year overall shunt survival rate were also investigated.The one-year survival rate for proximal catheters in each location was further investigated, and the rates were compared among locations.The factors affecting proximal catheter survival were determined.Results the one-year overall shunt survival rate of mvps with y was 70%, which was not much different from that of previously reported single vpss, including our institution.We found no significant factor influencing overall shunt survival, but when an additional catheter was inserted into the fourth ventricle, the survival rate was exceptionally low at 40% (p = 0.21).When we investigated the one-year survival rate of each proximal catheter, we found that the location of the proximal catheter showed a certain trend toward significance (p = 0.07), especially in the case of the fourth ventricle, which had the lowest survival rate at 57% and an odds ratio of 15.64 (p = 0.013) in multivariate analysis.However, when the catheter was sufficiently inserted parallel to the brain stem using navigation, the survival was relatively well maintained (1,995 to 2,547 days).Conclusions the stability of mvps with y was similar to that of single vpss.However, the malfunction rate of the proximal catheter inserted at the fourth ventricle in the y-connection was higher than that at other locations.The transcerebellar vertical approach or transtentorial approach parallel to the brain stem may decrease the malfunction rate.Reported events: - the most common cause of one-year overall failure leading to shunt revision was a newly ev in a different location (4/33).Regarding the cause of shunt failure, there were two proximal catheter malfunctions and one valve or distal catheter malfunction.Other causes were infection and wound dehiscence (one case for each), and there was no problem with the y-connector.The following valves were used 18 42856 strata ii valve, small; 12 42866 strata ii valve, regular; 2 42314 csf-flow control, contoured small, medium pressure; however, the article did not indicate which valves were associated with the failures.

Manufacturer Narrative

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

• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12980539
• MDR Text Key: 282096485
• Report Number: 2021898-2021-00216
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• 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: 11/29/2021
• 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