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

Model Number UNKNOWN-V

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

Patient Problems Intracranial Hemorrhage (1891); Unspecified Infection (1930); Seroma (2069); Convulsion/Seizure (4406)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Xiangtong zhang, xiaofeng fang, aili gao2, dong guan, chunmei guo, sen wang, yongan chen, boxian zhao, kongbin yang, enxi hu, hongsheng liang, fulan hu.Safety analysis of simultaneous cranioplasty and ventriculoperitoneal shunt placement.Turkish neurosurger (2021).Doi: 10.5137/1019-5149.Jtn.30740-20.2 abstract aim: to investigate the safety of combined cranioplasty (cp) and ventriculoperitoneal shunt (vps) placement.Furthermore, we investigated whether the sequence of these procedures affects the postoperative complication rates associated with staged cp and vps placement.Material and methods: we retrospectively investigated patients who developed communicating hydrocephalus after decompressive craniectomy and subsequently underwent vps placement and cp at the hospital at which this study was performed between (b)(6) 2009 and (b)(6) 2019.Patients were categorized into group 1 (simultaneous cp and vps placement) and group 2 (cp and vps placement performed separately).Group 2 was subcategorized into subgroup 2a (cp performed before vps placement) and subgroup 2b (vps placement performed before cp).The student¿s t and chi square tests were used to analyze intergroup differences.Results: this study included 86 patients; 22 in group 1 and 64 in group 2 (24 patients in subgroup 2a and 40 patients in subgroup 2b).No statistically significant difference was observed in the overall complication rates between groups 1 and 2 (36.4% vs.28.1%, p=0.591).However, the incidence of infections was significantly higher in group 1 than in group 2 (22.7% vs.4.7%, p=0.024).Subgroup analysis showed that the overall complication rate was significantly lower in subgroup 2a than in subgroup 2b (12.5% vs.37.5%, p=0.031).Conclusion: simultaneous cp and vps placement is associated with a high incidence of infections.Moreover, compared with initial cp, initial vps placement is associated with a significantly higher risk of overall complications in patients who undergo a staged procedure.Reported events: - postoperative complications occurred in 26 of 86 patients (30.2%), including infection in 8 patients (5 in group 1, 3 in group 2), obstruction in 3 patients (group 2), seizure in 3 patients (1 in group 1, 2 in group 2), epidural hemorrhage in 3 patients (group 2), epidural hygroma in 8 patients (3 in group 1, 5 in group 2), and sinking skin flap syndrome (ssfs)/paradoxical herniation in 6 patients (group 2).See attached literature article.

• Brand Name: UNKNOWN VALVE/SHUNT
• 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: david gustafson ; 9775 toledo way; irvine, CA 92618 ; 7635149628
• MDR Report Key: 12001485
• MDR Text Key: 256273747
• Report Number: 2021898-2021-00129
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2021

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-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2021
• Initial Date FDA Received: 06/15/2021
• 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