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 2018-08-24 for DURASEAL, UNKNOWN XXX-DURASEAL manufactured by Integra Lifesciences Corp.
[118213802]
It is unknown if the device involved will be returned to the manufacturer for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. This can also be found online at : doi: https://doi. Org/10. 1016/j. Wneu. 2017. 08. 061. Linked to mfg. Report number: 1121308-2018-00058, 1121308-2018-00059 and 1121308-2018-00060.
Patient Sequence No: 1, Text Type: N, H10
[118213803]
This report is 2 of 4: world neurosurgery (2017) published, "comparison of porcine and bovine collagen dural substitutes in posterior fossa decompression for chiari i malformation in adults?. The study aims to examine whether the collagen matrix dural substitute type correlated with the incidence of postoperative complications after posterior fossa decompression in adult patients with chiari i malformations. Methods: a retrospective cohort study was conducted of 81 adult patients between june 2008 and january 2015 at a single center who underwent an elective decompressive surgery for treatment of symptomatic chiari i malformations, with duraplasty involving a dural substitute derived from either bovine or porcine collagen matrix. Demographics and treatment characteristics were correlated with surgical outcomes. One group of patients underwent duraplasty using bovine dural substitutes (n = 42), most of which were durepair (n = 36; composed of type i and type iii collagen derived from fetal bovine tissue [medtronic]). Of these patients, in 17 the duraplasty was augmented with a second onlay layer using duragen/duragen xs (composed of type i collagen derived from bovine achilles tendon). The other bovine dural substitutes used were suturable duragen (n = 3; composed of type i collagen from bovine achilles tendon), dura-matrix (n = 1; composed of type i collagen from bovine achilles tendon [stryker]), and duramatrix-onlay used for duraplasty and for onlay (n = 2; composed of type i collagen from bovine achilles tendon [stryker]). A second group of patients underwent duraplasty using a porcine dural substitute, biodesign dural graft (n =39; composed of collagen derived from porcine small intestine submucosa [cook biomedical]). In some cases (n = 19), after a bovine dural graft substitute had been used as a patch graft, an additional layer of onlay bovine dural graft material (duragen or duramatrix-onlay) was placed over the primary closure (without sutures) in such a way that it overlapped the suture lines of the patch graft. A dural sealant, either fibrin glue (tisseel [baxter]) or polyethylene glycol (duraseal), was applied over the suture lines and the patch graft to further reinforce the duraplasty. Results: in total, postoperative complications occurred in 18 patients, 5 of whom were in the bovine dural substitute group and 13 of whom (were in the porcine dural substitute group. Within the bovine dural substitute group, postoperative complications occurred in 5 patients (11. 9%), 3 of whom (7. 1%) had aseptic meningitis. One patient (2. 4%) had possible bacterial meningitis, with an equivocal result of gram-positive cocci in csf from lumbar puncture. Two of the 3 patients with aseptic meningitis also had pseudomeningoceles. These patients with pseudomeningocele recovered without further complications. One additional patient with a pseudomeningocele subsequently developed evidence of hydrocephalus and underwent placement of a ventriculoperitoneal shunt; this was the only occurrence of a repeat operation for any cause. There were no occurrences of external csf leak in the bovine dural substitute group. Conclusion: in posterior fossa decompression surgery with duraplasty to correct symptomatic chiari i malformations in adults, use of a porcine dural graft substitute was associated with a higher likelihood of pseudomeningocele development compared with use of bovine dural graft substitutes. The incidence of csf leak, meningitis, or repeat operations was not significantly different between the 2 dural substitute types. Further studies are needed to optimize the materials and surgical approach for the treatment of chiari i malformations in adults.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2018-00037 |
| MDR Report Key | 7814287 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2018-08-24 |
| Date of Report | 2018-07-31 |
| Date Mfgr Received | 2018-08-31 |
| Date Added to Maude | 2018-08-24 |
| 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 | 2018-08-24 |
| 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 | 2018-08-24 |