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

Model Number UNKNOWN-C

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 05/05/2021

Event Type  Injury  

Event Description

Shota yamashita, tomomi kimiwada, toshiaki hayashi, reizo shirane , and teiji tomonaga.Reconversion to ventriculoperitoneal shunt following ventriculoatrial shunt malfunction in children.Child's nervous system 37 (2021).Doi: 10.1007/s00381-021-05045-7 abstract purpose to analyze the long-term efficacy of the ventriculoatrial shunt (vas) in pediatric patients with hydrocephalus, focusing on the atrial catheter and suitable revision procedures of the distal catheter following vas malformation performed at our institution.Methods the authors retrospectively analyzed data of 28 pediatric patients under the age of 10 years who were treated with vas for hydrocephalus and who had a follow-up period of at least 5 years.Results a total of 42 atrial tube revision procedures were performed in 28 patients during the study period.The median atrial tube survival time due to atrial tube obstruction was 2.32 years (n = 31, range: 0.4¿8.08 years).Atrial tube survival time was shorter in younger children (p <(><<)> 0.0001) and in children who were shorter in height (p = 0.0001).As a revision procedure following atrial tube malfunction, 22 (78.6%) out of the 28 patients who had an inserted vas had the vas reconversion into a vps at the last follow-up.Conclusions vas can be a useful alternative to vps, but it requires frequent atrial tube revisions, especially in younger children.Reconversion to vps after vas malfunction is a reasonable option and is associated with longer shunt survival time despite its previously observed difficulties.Reported events.Of the 28 patients with vas placements, 1 patient (3.6%) required no revision at the time of the last follow-up.A total of 42 atrial tube revision procedures were performed in 27 patients (96.4%) during the study period.It should be noted that procedures without atrial tube revisions (only proximal tube or valve) were not included in this study.The most common reason for atrial tube revision was atrial tube obstruction in 20 patients of 31 revisions (73.8%), followed by infection in 3 patients of 6 revisions (14.3%).Five (11.9%) atrial tube revision procedures were performed for the purpose of elective atrial tube lengthening to prevent catheter obstruction.No patient suffered from atrial catheter-related complications such as shunt nephritis, venous thrombosis, and cardiopulmonary complications.

Manufacturer Narrative

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

Manufacturer Narrative

H2) additional information was added to the b5.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.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.

Event Description

Additional information was received stating that the manufacturer representative (rep) could not visit the hospital to meet the author due to visitor restriction by the covid-19.However, they obtained information from the rep.Regarding the atrial catheter in the article, the products 43418, 27328, and 25024, have been used at the hospital.But they also have used other companies' catheters because the products have had an issue of chronic stockout for these two years.Therefore, it was not identified how many events, which mentioned in the article, occurred on medtronic products or which products were involved.The rep has reported some events of this hospital that valve blockage was suspected several times but these were events of valve verification, not about catheters.The doctor always reaches out to the rep if an event occurs and our products are involved.Therefore the rep is assuming that the events in which the doctor has not reported to the rep are the patient's origin and so on.

• Brand Name: UNKNOWN CATHETER
• 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: 13079106
• MDR Text Key: 286666916
• Report Number: 2021898-2021-00226
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 03/18/2022

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 Operator: Health Professional
• Device Model Number: UNKNOWN-C
• Device Catalogue Number: UNKNOWN-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/23/2021
• Supplement Dates Manufacturer Received: 03/16/2022
• Supplement Dates FDA Received: 03/20/2022
• 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