MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION DURAGEN DURAL GRAFT MATRIX; N/A

Catalog Number DURAGEN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cerebrospinal Fluid Leakage (1772); Meningitis (2389)

Event Type  Injury  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.Linked to mfg report number: 3003418325-2018-00007 (same patient) other mfg.Report numbers: 3003418325-2018-00006, 1121308-2018-00021, 3003418325-2018-00008, 1121308-2018-00023.

Event Description

World neurosurgery (2017) published ¿candida meningitis after transsphenoidal surgery: a single institution case-series and literature review¿ which discussed three case presentations of patients with giant skull base tumors who developed post-surgical candida meningitis, each with vastly different clinical courses and outcomes.Duraseal and duragen were used for each of the patients.This is a case of a (b)(6) male presented with bitemporal hemianopsia noted by his ophthalmologist who was following him for cataracts.Brain mri demonstrated a giant, 4 cm homogeneously enhancing sellar mass with suprasellar extension compressing the optic apparatus and extending into the cavernous sinus bilaterally.He subsequently underwent a transnasal transsphenoidal resection of a nonsecreting pituitary adenoma.Cerebrospinal fluid (csf) was encountered and the defect was repaired with a left pedicled nasoseptal flap, duragen, duraseal, avitene wrapped in surgicel, and merocel packs.One week later, he presented with csf rhinorrhea, altered mental status, and fevers, at which time he underwent surgical repair with a right nasal floor free mucosal graft, duraseal, and avitene wrapped in surgicel.Csf cultures were positive for coagulase-negative staphylococcus meningitis, which was treated initially with vancomycin and cefepime, and later with ceftriaxone.Six weeks later, he presented with recurrent csf rhinorrhea and headache and head computerized axial tomography (ct) demonstrated pneumocephalus.He returned to the operating room for endoscopic exploration and repair with a modified gasket seal technique, duragen, fascia lata graft harvest, fat graft harvest, and attempted lumbar drain.He remained intubated to avoid worsening pneumocephalus and a lumbar drain was placed three days later for persistent csf rhinorrhea.At this time, csf cultures were positive for candida albicans, and fluconazole was added to his previous regimen of vancomycin, cefepime, and metronidazole.Ten days later, due to persistent csf rhinorrhea, he underwent a transnasal endoscopic regional middle turbinate rotational flap and placement of a right frontal ventriculoperitoneal shunt.One month following this, he presented with pneumocephalus and underwent a bicoronal incision with pericranial flap and an additional middle turbinate flap with abdominal fat graft.The leak persisted and 10 days later, he underwent another endoscopic repair with more abdominal fat graft as well as a free mucosal graft from the nasal septum.This was topped with tisseel, duraseal, floseal, and a 30 ml foley catheter, while surgicel and avitene were placed around the catheter.He had no further rhinorrhea and was doing well at his follow-up 10 months later.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation.No dhr review was possible since no lot number was reported.The reported condition is unconfirmed.The root cause is undetermined.

• Brand Name: DURAGEN DURAL GRAFT MATRIX
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; 105 morgan lane; 105 morgan lane; plainsboro NJ 08536
• MDR Report Key: 7340844
• MDR Text Key: 102451663
• Report Number: 1121308-2018-00022
• Device Sequence Number: 1
• Product Code: GXQ
• Combination Product (y/n): N
• PMA/PMN Number: K982180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DURAGEN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 30ML FOLEY CATHETER; AVITENE (BARD DAVOL); DURASEAL; FLOSEAL (BAXTER); MEROCEL PACK; NASOSEPTAL FLAP; SURGICEL; TISEEL (BAXTER); VENTRICULOPERITONEAL SHUNT; 30ML FOLEY CATHETER; AVITENE (BARD DAVOL); DURASEAL; FLOSEAL (BAXTER); MEROCEL PACK; NASOSEPTAL FLAP; SURGICEL; TISEEL (BAXTER); VENTRICULOPERITONEAL SHUNT
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 75 YR