MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2019-04-04 for DURASEAL, UNKNOWN XXX-DURASEAL manufactured by Integra Lifesciences Corp.
[140906562]
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.
Patient Sequence No: 1, Text Type: N, H10
[140906563]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00010 |
| MDR Report Key | 8482348 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2019-04-04 |
| Date of Report | 2019-03-14 |
| Date Mfgr Received | 2019-04-05 |
| Date Added to Maude | 2019-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURASEAL, UNKNOWN |
| Generic Name | DURASEAL CRANIAL |
| Product Code | NQR |
| Date Received | 2019-04-04 |
| Catalog Number | XXX-DURASEAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-04 |