MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA®; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number UNKNOWN-A

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Pleural Effusion (2010)

Event Date 08/13/2021

Event Type  Injury  

Event Description

Christian, e.A., quezada, j.J., melamed, e.F., lai, c., mccomb, j.G.Ventriculopleural shunts in a pediatric population: a review of 170 consecutive patients.J neurosurg pediatr.2021.(28) 450¿457.Doi: 10.3171/2021.3.Peds2176.Objective the authors sought to determine the outcome of using the pleural space as the terminus for ventricular csf-diverting shunts in a pediatric population.Methods all ventriculopleural (vpl) shunt insertions or revisions done between 1978 and 2018 in patients at children¿s hospital los angeles were identified.Data recorded for analysis were age, sex, weight, etiology of hydrocephalus, previous shunt history, reason for vpl shunt insertion or conversion from a ventriculoperitoneal (vp) or ventriculoatrial (va) shunt, valve type, nature of malfunction, presence of shunt infection or pleural effusion, and conversion to a different distal site.Results a total of 170 patients (mean age 14 ± 4 years) with a vpl shunt who were followed up for a mean of 57 ± 53 months were identified.The reasons for conversion to a vpl shunt for 167 patients were previous shunt infection in 57 (34%), multiple abdominal procedures in 44 (26%), inadequate absorption of csf in 34 (20%), abdominal pseudocyst in 25 (15%), and obesity in 7 (4%).No vpl revisions were required in 97 (57%) patients.Of the 73 (43%) patients who did require revision, the most common reason was proximal obstruction in 32 (44%).The next most frequent complication was pleural effusion in 22 (30%) and included 3 patients with shunt infection.All 22 patients with a clinically significant pleural effusion required changing the distal end of the shunt from the pleural space.Pleural effusion was more likely to occur in vpl shunts without an antisiphon valve.Of the 29 children <(><<)> 10 years old, 7 (24%) developed a pleural effusion requiring a revision of the distal catheter to outside the pleural space compared with 15 (11%) who were older (p = 0.049).There were 14 shunt infections with a rate of 4.2% per procedure and 8.2% per patient.Conclusions vpl shunts in children younger than 10 years of age have a significantly higher rate of symptomatic pleural effusion, requiring revision of the shunt¿s terminus to a different location.Vpl shunt complication rates are similar to those of vp shunts.The technical difficulty of inserting a vpl shunt is comparable to that of a vp shunt.In a patient older than 10 years, all else being equal, the authors recommend that the distal end of a shunt be placed into the pleural space rather than the right atrium if the peritoneal cavity is not suitable.Reported events: multiple abdominal procedures in 44 (26%) abdominal pseudocyst in 25 (15%) proximal obstruction in 32 (44%) reason for revision surgery pleural effusion in 22 (30%) reason for revision surgery including 3 patients with shunt infection.Intraventricular hemorrhage in 31 patients revision surgeries in 17 patients infections 10 patients revision surgery in 5 (6%) patients total of 73 revised procedures shunt infections in 57 patients revision surgery in 17 (34%) patients delta 1 valve used in 38 patients revision surgery in 15 patients delta 1.5 valve used in 27 patients revision surgery in 12 patients delta 2 valve used in 60 patients revision surgery in 26 patients delta 3 valve used in 2 patients revision surgery in 1 patient strata programmable used in 12 patients revision surgery in 5 patients vpl shunt conversion occurred in 22 (13%) patients all 22 patients with a clinically significant pleural effusion required relocation of the distal end of the shunt from the pleural space 1 (1%) patient had persistent pain at the thoracic incision site that resolved when the distal end was placed in the peritoneum 7 (24%) patients developed a pleural effusion requiring a revision 5 (36%) patients were associated with a previous shunt infection.

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DELTA®
• 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: 14210421
• MDR Text Key: 290089957
• Report Number: 2021898-2022-00105
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-A
• Device Catalogue Number: UNKNOWN-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 14 YR
• Patient Sex: Male