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

Model Number UNKNOWN-C

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Cyst(s) (1800)

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, sim ultaneous 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 o bstruction (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 affectedby 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, 31 (53.4%) were related to proximal obstruction, 8 (13.8%) were related to distal obstruction, and 3 (5.2%) were related to both proximal and distal obstruction.Of the 58 total failures in the cv group, 5 (8.6%) were related to a pseudocyst.See attached literature article.

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, sim ultaneous 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 o bstruction (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 affectedby 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, 31 (53.4%) were related to proximal obstruction, 8 (13.8%) were related to distal obstruction, and 3 (5.2%) were related to both proximal and distal obstruction.Of the 58 total failures in the cv group, 5 (8.6%) were related to a pseudocyst.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.See attached literature article.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN CATHETER
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9614151
• MDR Text Key: 198536009
• Report Number: 2021898-2020-00031
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• 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-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention