MAUDE Adverse Event Report: COVIDIEN LLC UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number UNKNOWN-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 10/15/2022

Event Type  Injury  

Manufacturer Narrative

No parts have been returned for analysis.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.

Event Description

Dayong han front.Neurol 13:1001829.30 august, 2022 doi: 10.3389/fneur.2022.1001829 background: glioma is the most common primary brain tumor in adults with poor prognosis.The glioma patients benefit from stupp strategy, including maximum and safe resection and adjuvant radiotherapy and chemotherapy.Arsenic trioxide could inhibit various tumors.However, it is a challenge to evaluate the efficiency and safety of arsenic trioxide in glioma patients.Objective: the arsenic trioxide has the potent therapeutic effect on glioma.However, the safety and efficacy of local interstitial chemotherapy with arsenic trioxide in newly diagnosed glioma patients is unclear.Methods: all patients received partial or complete tumor resection and intraoperative implantation of ommaya reservoirs followed by standard radiotherapy.Arsenic trioxide with the starting dose 0.3mg was administered via an ommaya reservoir catheter inserted into the tumor cavity for 5 consecutive days every 3 months for a total of eight cycles unless tumor progression or excessive toxicity was observed.Results: no hematological or grade 4 non-hematological toxicity was observed in any patient during arsenic trioxide treatment.The maximum tolerated dose of 1.5mg of arsenic trioxide was safe and well tolerated.The median overall survival for who grade 3 glioma was 33.6 months, and for glioblastoma was 13.9months.Themedian progression-free survival for who grade 2 glioma was 40.3 months, for grade 3 glioma was 21.5 months, and for glioblastoma was 9.5 months.Conclusion: these results suggest that arsenic trioxide is safe and well tolerated with local delivery into the tumor cavity of the brain, and the dose recommended for a phase ii trial is 1.5 mg.Serious injury events: 1 reservoir was explanted due to an infection at the surgical site.

• Brand Name: UNKNOWN EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Type of Device: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15625974
• MDR Text Key: 301931840
• Report Number: 9612501-2022-01801
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-E
• Device Catalogue Number: UNKNOWN-E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR