MAUDE Adverse Event Report: INTEGRA LIFE SCIENCES CORP DURASEAL, UNKNOWN; DURASEAL CRANIAL

Catalog Number XXX-DURASEAL

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 linked to mfg report number 3003418325-2022-00013: scientific reports (2022) published an article: "fibrin-coated collagen fleece versus absorbable dural sealant for sellar closure after transsphenoidal pituitary surgery: a comparative study." various surgical methods to prevent postoperative cerebrospinal fluid (csf) leaks during transsphenoidal surgery have been reported.However, comparative studies are scarce.We aimed to compare the efficacy of a fibrin-coated collagen fleece (tachosil) versus a dural sealant (duraseal) to prevent postoperative csf leakage.We perform a retrospective study comparing two methods of sellar closure during endoscopic endonasal transsphenoidal surgery (eets) for pituitary adenoma resection: tachosil patching versus duraseal packing.Data concerning diagnosis, reconstruction technique, and surgical outcomes were analyzed.The primary endpoint was postoperative csf leak rate.We reviewed 198 consecutive patients who underwent 219 eets for pituitary adenoma from february 2007 and july 2018.Lntraoperative csf leak occurred in 47 cases (21.5%).A total of 33 postoperative csf leaks were observed (15.1%).A reduction of postoperative csf leaks in the tachosil application group compared to the conventional technique using duraseal was observed (7.7% and18.2%, respectively; p = 0.062; pearson exact test) although non-statistically significant.Two patients required lumbar drainage, and no revision repair was necessary to treat postoperative csf rhinorrhea in tachosil group.Fibrin-coated collagen fleece patching may be a valuable method to prevent postoperative cerebrospinal fluid (csf) leaks during eets for pituitary adenoma resection.Intraoperative csf leaks were classified in operative protocols as « low » flow csf leaks which are small "weeping" leaks flowing even without valsalva maneuver and "high'' flow csf leaks which are moderate or large csf leaks with or without obvious diaphragmatic defect.In the instance of an intraoperative csf leak, the postoperative cavity dead space was usually filled with a small piece of absorbable gelatin foam (gelfoam; upjohn, kalamazoo, mi) to reduce the amount of csf leak.For "low" flow csf leaks, the closure was then performed as described in the surgical technique for each cohort.For "high'' flow leaks, an additional covering by an autologous tissue (turbinate cartilage or septa! bone) of the sellar opening was used before classical closure for each cohort.Before 2015, we used in our practice a conventional sellar closure technique with the dural sealant closure (duraseal).In 2015, as we aimed to reduce the incidence of postoperative csf leaks, we opted for a promising alternative method using a fibrin-coated collagen fleece (tachosil).Malfunction - intraoperative csf leaks were classified in operative protocols as "low" flow csf leaks which are small "weeping" leaks flowing even without valvalva maneuver and "high" flow csf leaks which are moderate or large csf leaks with or without obvious diaphragmatic defect.Conclusion - fibrin-coated collagen fleece patching may be a valuable method to prevent csf leaks during eets for pituitary adenoma resection.This study reports fewer postoperative leaks in the tachosil cohort compared to the duraseal cohort without reaching significance.This observation dovetails with previous surgical series and experimental data but powered studies to achieve higher levels of evidence are required to confirm these results.Doi.Org/10.1038/s41598-022-12059-x nature portfolio.

Manufacturer Narrative

Duraseal was not returned for evaluation and no lot number was provided/identified, as such a specific dhr review could not be performed.However, at the time of manufacturing, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications.With the information provided a root cause could not be determined, as there is no way to reliably determine why the reported condition occurred.Most likely root cause could not be determined, however "csf leak" has an acceptable risk of performance, solution mixing and coverage with an improbable occurrence.No further investigation is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended for future potential action should new information become available, the file will be re-opened and the investigation will be amended as appropriate.

• Brand Name: DURASEAL, UNKNOWN
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFE SCIENCES CORP; 1100 campus drive; 1100 campus drive; princeton NJ
• Manufacturer (Section G): INTEGRA LIFE SCIENCES CORP; 1100 campus drive; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15233412
• MDR Text Key: 305597315
• Report Number: 3003418325-2022-00014
• 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: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURASEAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• 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