MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2017-07-07 for NBCA LIQUID EMBOLIC SYSTEM UNK-CNV_NBCA manufactured by Codman And Shurtleff, Inc.
[79274785]
This submission is related to a literature article discovered in an effort to support the cer submission process, as such, the associated time frame of event dates includes but is not limited to 20 years. These articles are being reviewed on a monthly basis for safety signals and will be followed by monthly trending assessments as well as pms reviews. Date of event, product code, and lot number could not be obtained from the author. Unknown part number, attempts to obtain product part number were unsuccessful, udi unavailable. Conclusion: the products were not available for analysis. In addition, the lot numbers were not available; therefore, a dhr could not be performed. Passage of embolic material into normal vessels adjacent to the lesion is a known potential adverse event associated with embolization procedures. The root cause of the event could not be conclusively determined; however, the author attributed the symptoms to the occlusion of the entire carotid sinus. There is no current safety signal identified related to the reported events based on review of complaint histories for the device. Since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time. This is an initial/final mdr report.
Patient Sequence No: 1, Text Type: N, H10
[79274786]
In the literature article? Transvenous n-butyl-cyanoacrylate infusion for complex dural carotid cavernous fistulas: technical considerations and clinical outcome? By ajay k. Wakhloo, alain perlow, italo linfante, johnny s. Sandhu, john cameron, neil troffkin, alexander schenck, norman j. Schatz, david t. Tse, and byron l. Lam, published ajnr am j neuroradiol 26:1888? 1897, september 2005, n-bca (catalog/lot not reported in article) spillage into the superior ophthalmic vein was reported in the patient 4. The (b)(6) female patient had presented with symptoms of chemosis, decreased visual acuity and ophthalmoplegia. Angiogram showed a ccf (carotid cavernous fistula) with bilateral mixed dural artery supply both via the external and internal carotid arteries (type d), congestion of both cavernous segments with retrograde flow in both superior ophthalmic vein (sov). A transvenous embolization was carried out by using n-bca with complete ccf obliteration and cure of symptoms. Frontal and lateral radiograph showed the n-bca-ethiodol cast within the (carotid sinus (cs) bilaterally. Some embolic material spillage was seen in the right proximal sov through the stenotic segment. Reflux of n-bca into the proximal sov occurred without a clinical sequela. The article presented retrospective evaluation of 14 patients with dural carotid cavernous fistulas (dccfs) who were treated from 1999 to 2004 by using n-bca infusion alone or in combination with coils. The efficacy of treatment and safety aspects were studied in dccfs of barrow type b (4/14), c (2/14), and d (8/14). Six patients were treated with transvenous n-bca infusion alone in the cavernous sinus, 7 with a combination of transvenous n-bca and coil embolization, and one with transvenous n-bca combined with transarterial polyvinyl alcohol (pva)? Particle embolization of the feeding arteries. The average age of the patients was 63 years (range, 35? 93 years). Six patients were men and 8 were women.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2017-00105 |
| MDR Report Key | 6693170 |
| Report Source | LITERATURE |
| Date Received | 2017-07-07 |
| Date of Report | 2017-06-12 |
| Date of Event | 2005-09-01 |
| Date Mfgr Received | 2017-06-12 |
| Date Added to Maude | 2017-07-07 |
| 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 | KAREN ANIGBO |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088288374 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NBCA LIQUID EMBOLIC SYSTEM |
| Generic Name | TRUFILL N_BCA |
| Product Code | KGG |
| Date Received | 2017-07-07 |
| Model Number | NA |
| Catalog Number | UNK-CNV_NBCA |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN AND SHURTLEFF, INC |
| Manufacturer Address | 325 PARAMOUNT DR RAYNHAM MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2017-07-07 |