MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-04-01 for DURASEAL, UNKNOWN XXX-DURASEAL manufactured by Integra Lifesciences Corp.
[140529050]
The device is not expected to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[140529052]
The world neurosurgery journal (2018) published "comparison of dural peeling versus duraplasty for surgical treatment of chiari type i malformation: results and complications in a monocentric patients? Cohort". The aim of our study was to analyze the outcome of a less invasive cranio-cervical decompression (ccd) in cm-i using a dural peeling (dpe) technique. The primary endpoint of this study was to compare efficacy and complications rate of ccd using dural peeling (dpe) versus duraplasty (dp). The secondary end point was to find predictive factors of success of dpe. Twenty-eight consecutive patients with chiari malformation type i (12 women and 16 men) requiring ccd were enrolled at our institution between august 2011 and november 2015. Ten patients (35. 7%) underwent dp, and 18 (64. 3%) dpe. A standardized magnetic resonance imaging protocol was performed before and at least 3 months after surgery. Symptomatic outcome was evaluated at the last follow-up visit. In the dp group, the dura was opened by a linear path without cauterization or resection of cerebellar tonsils. Dural grafting was completed using various materials according to the surgeon? S preference: tissudura (baxter) covered with duraseal (n =1); neuro-patch (b braun, melsungen) alone (n = 1), covered with duraseal (n = 5) or tisseel (baxter) (n = 2); or fascia lata (tissue bank, ucl) (n = 1). In the dpe group, after bone removal, the outer layer of the dura was peeled carefully to avoid penetration into the subarachnoid spaces. Once sufficient thinning of the dura was obtained, it could be seen pulsating under the microscope. After meticulous hemostasis, the wound was closed in standard layered fashion. All the patients were admitted to the intensive care unit postoperatively. All patients in the dp group clinically improved, with half (50%) having complete resolution of symptoms and the remaining half having partial improvement. In the dpe group, only 66. 7% of patients had clinical improvement, 28% with total resolution and 39% with partial improvement. Six patients (33%) in the dpe group have not benefited from any clinical improvement. Overall complications were more frequent in the dp (70%) than in the dpe (0%) group (p < 0. 05). Four patients (40%) in the dp group required multiple interventions because of complications (1 pseudomeningocele, 1 wound infection, and 2 hydrocephalus). In the dpe group, 2 patients needed a late second surgery with dp because of the nonresolution of the preoperative symptoms. All patients in the dp group had at least partial improvement of preoperative symptoms, but 4 (40%) needed a second surgery for postoperative complications. Conclusion: ccd with dpe was less risky than with dp but had a lower responsive rate (66. 7% vs. 100). Larger studies are therefore warranted to assess predictive factors of success of ccd with dpe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00007 |
| MDR Report Key | 8470620 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-04-01 |
| Date of Report | 2019-03-14 |
| Date Mfgr Received | 2019-04-26 |
| Date Added to Maude | 2019-04-01 |
| 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 | MS. 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 | 2019-04-01 |
| Catalog Number | XXX-DURASEAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2019-04-01 |