MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP 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); Visual Impairment (2138); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The device is unlikely to be returned to the manufacturer for analysis as it still is currently implanted to the patient.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.(b)(4).Doi: https://doi.Org/10.1055/s-0037-1604484.

Event Description

Journal of neurological surgery (2018) published ¿comparative cost analysis of endoscopic versus microscopic endonasal transsphenoidal surgery for pituitary adenomas.¿ the purpose of the study was to present a comparative analysis of cost efficacy between the microscopic and endoscopic transsphenoidal approaches, evaluating neurological outcome, extent of resection (eor), and inpatient hospital costs.Methods: thirty four patients were found to have undergone a microscopic approach transsphenoidal surgery for a pituitary adenoma between jan2007 and jan2014.The matched group consisted of a retrospective cohort of 34 patients who underwent an endoscopic endonasal transsphenoidal surgery between the same time period.Following surgery, patients were monitored and managed for diabetes insipidus and followed up postoperatively at 1 month, 6 months, and then annually.Microscopic and endoscopic approaches: following the tumor resection, the sellar space was reconstructed with an autologous abdominal fat graft, hemostatic cellulose polymer (surgicel, ethicon) and dural sealant (duraseal).Results: total inpatient costs per patient was less in the endoscopic group.Operating room costs were lower in the endoscopic group.Operative time was more in the microscopic group than in the endoscopic group.The qaly score, length of the hospital stay, and postoperative outcomes were found to be similar between the two cohorts.Multivariate linear regression modeling suggested that length of stay and operative time were important factors that influenced total inpatient costs following transsphenoidal surgery.Outcomes/complications: microscopic patients: 2 vision worsened, 2 cerebrospinal fluid (csf) leaks, 11.8% adrenal insufficiency, 2.9 % hypothyroidism, 20.6% transient diabetes insipidus.Endoscopic patients: 1 vision worsened, 1 cerebrospinal fluid (csf) leak, 1 internal carotid artery (ica) violated, 1 stroke, 14.7% adrenal insufficiency, 14.7% transient diabetes insipidus.All three patients with postoperative csf leak were treated with a lumbar drain.Diabetes insipidus patients from both cohorts were initially treated with subcutaneous vasopressin that was transitioned to an oral desmopressin dose that was tapered off in the outpatient setting by an endocrinologist.Conclusion: the study showed that transsphenoidal surgery is more cost effective with endoscopic approach than with the microscopic approach and depends on efficiency in the operating room as well as reduction in the length of hospitalization.

Event Description

N/a.

Manufacturer Narrative

The device was not returned for evaluation.There was no product received back, as such only a dhr review was conducted.The dhr review concluded there were no assembly component related failures at the time of release.The reported complaint was not confirmed.With the information provided a root cause could not be reliably determined.

• Brand Name: DURASEAL, UNKNOWN
• Type of Device: DURASEAL CRANIAL
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP; 311 enterprise drive; 311 enterprise drive; plainsboro NJ 08536
• MDR Report Key: 8482348
• MDR Text Key: 140906562
• Report Number: 3003418325-2019-00010
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-DURASEAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 04/05/2019
• Supplement Dates FDA Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1