MAUDE Adverse Event Report: INTEGRA - PRINCETON DURASEAL, UNKNOWN; DURASEAL CRANIAL

Catalog Number XXX-DURASEAL

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache (1880); Nausea (1970)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

This is 2 of 2 reports for case 4 in the article (duraseal), which is linked to mfg report number 1121308-2022-00107: interdisciplinary neurosurgery 16 (2019) published an article: "treatment of postoperative recurrent cerebrospinal fluid leak with pseudomeningocele formation using temporary epidural drain." objective: treatment of cerebrospinal fluid (csf) leak with pseudo meningocele formation can be challenging; especially when attempts to repair it fail.In this paper the authors present four cases in which the problem was fixed using temporary epidural drain.Patients and methods: four patients were treated with this approach over the last 15 years.One patient had cranio­cervical decompression for chiari malformation with two attempts to fix the csf leak after the initial operation; two patients had one attempt at operative repair of the leak after the initial operation; and one patient had an attempt to repair of the leak during the initial procedure.Epidural drains were placed percutaneously under local anesthesia.Results: within 2­-3 days the wounds were dry and flat.After one week the drains were removed.None of the patients had recurrence of the leak.There was no complication from the drain placement.Conclusion: placement of the epidural catheter is a simple and minimally invasive procedure that solved a complex problem in these four patients.Considering the simplicity of this procedure it is worthwhile trying it prior to considering reoperation.Case 4 a 55-year male presented with pain radiating into left leg with weak dorsiflexion.Mri show lateral recess stenosis at l5-sl level on the left side.A laminectomy at ls and decompression of the left lateral recess was performed.There was csf leak upon removal of the ligamentum flavum.The dura had shredded appearance with several small leaking spots.It was covered with duragen and duraseal.Valsalva maneuver was negative for leak.Patient was kept on bed rest for three days and then ambulated.He had no motor weakness and the wound was dry and flat.He was sent home.Seven days later he was readmitted with severe back pain, headache and nausea.His wound was bulging and ct scan showed large fluid collection in the epidural space that extended to the subcutaneous tissue.Epidural drainage protocol was initiated.This resulted in good resolution of the csf leak without further complication.The patient was discharged on day eight.At four-month follow-up his wound was dry and flat, he was asymptomatic except for low back pain, and he had good motor function.Mri showed small localized fluid collection posterior to the spinal canal without outward tracking of the fluid.Https:/ /doi.Org/10.1016/j.Inat.2018.11.006.

Manufacturer Narrative

Duraseal was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.However, all lots are reviewed to meet quality criteria before they are released.The root cause of the reported issue could not be determined.Per the dfmea, potential causes of failure include: performance, sealing dura, application - gel delivery, solution mixing and coverage.The risk remains acceptable per the risk analysis.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: DURASEAL, UNKNOWN
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15686572
• MDR Text Key: 302558818
• Report Number: 3003418325-2022-00028
• Device Sequence Number: 1
• Product Code: NQR
• Combination Product (y/n): N
• PMA/PMN Number: P040034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURASEAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male