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.

• 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

• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Date Manufacturer Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/23/2021 Patient Sequence Number: 1