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 Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Jeremy s.Wetzel, alex d.Waldman, pavlos texakalidis, bryan buster, sheila r.Eshraghi, jennifer wheelus, andrew reisner, and joshua j.Chern.Survival and failure trends of cerebrospinal fluid shunts with distal slit valves: comparative study and literature review.Journal of neurosurgery pediatrics.(2019).Doi: 10.3171/2019.9.Peds18579.Objective the malfunction rates of and trends in various cerebrospinal fluid (csf) shunt designs have been widely studied, but one area that has received little attention is the comparison of the peritoneal distal slit valve (dsv) shunt to other conventional valve (cv) type shunts.The literature that does exist comes from older case series that provide only indirect comparisons, and the conclusions are mixed.Here, the authors provide a direct comparison of the overall survival and failure trends of dsv shunts to those of other valve type shunts.Methods three hundred seventy-two new csf shunts were placed in pediatric patients at the authors¿ institution between january 2011 and december 2015.Only ventriculoperitoneal (vp) shunts were eligible for study inclusion.Ventriculoatrial, lumboperitoneal, cystoperitoneal, subdural-peritoneal, and spinal shunts were all excluded.Rates and patterns of shunt malfunction were compared, and survival curves were generated.Patterns of failure were categorized as proximal failure, distal failure, simultaneous proximal and distal (proximal+distal) failure, removal for infection, externalization for abdominal pseudocyst, and addition of a ventricular catheter for loculated hydrocephalus.Results a total of 232 vp shunts were included in the final analysis, 115 dsv shunts and 117 cv shunts.There was no difference in the overall failure rate or time to failure between the two groups, and the follow-up period was statistically similar between the groups.The dsv group had a failure rate of 54% and a mean time to failure of 17.8 months.The cv group had a failure rate of 50% (p = 0.50) and a mean time to failure of 18.5 months (p = 0.56).The overall shunt survival curves for these two groups were similar; however, the location of failure was significantly different between the two groups.Shunts with dsvs had proportionately more distal failures than the cv group (34% vs 14%, respectively, p = 0.009).Dsv shunts were also found to have proximal+distal catheter occlusions more frequently than cv shunts (23% vs 5%, respectively, p = 0.005).Cv shunts were found to have significantly more proximal failures than the dsv shunts (53% vs 27%, p = 0.028).However, the only failure type that carried a statistically significant adjusted hazard ratio in a multivariate analysis was proximal+distal catheter obstruction (cv vs dsv shunt: hr 0.21, 95% ci 0.05¿0.81).Conclusions there appears to be a difference in the location of catheter obstruction leading to the malfunction of shunts with dsvs compared to shunts with cvs; however, overall shunt survival is similar between the two.These failure types are also affected by other factors such etiology of hydrocephalus and endoscope use.The implications of these findings are unclear, and this topic warrants further investigation.Reported events.- of the 58 total failures in the cv group, 2 (3.4%) were related to valve obstruction.Of the 58 total failures in the cv group in this literature article, it was identified that the manufacturer's devices of fixed-pressure delta, ps medical, and strata valves were used; however, it is unclear which device was involved with the reported events.

• 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: 9614153
• MDR Text Key: 181759031
• Report Number: 2021898-2020-00032
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2020
• Is this an Adverse Event Report?: No
• 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: 01/15/2020
• 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