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 2016-10-04 for NBCA LIQUID EMBOLIC SYSTEM 2 UNK-CNV_NBCA manufactured by Codman And Shurtleff, Inc.
[56352438]
Literature article attached: picel a. C. , koo s. L. , roberts a. C. (august 2016)? Transcatheter arterial embolization with n-butyl cyanoacrylate for the treatment of acquired uterine vascular malformations?. Cardiovascular and interventional radiology. 39 (8) (pp 1170-1176). The author was not able to provide any additional information, including product code and catalog number and date of the procedure. Device manufacturing and expiration dates are unknown since lot and product codes could not be provided. This is (b)(4) associated with this literature article with associated (b)(4). Udi: the product code and lot number were not available; therefore udi is unknown. Conclusion: the device was not available for analysis. In addition, the lot number could not be provided; therefore, a dhr review could not be performed. Failed attempt to embolize the avm is a known adverse event associated with nbca glue. The trufill system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (avms) via superselective catheter delivery. The root cause of the embolization failure could not be determined; however, procedural or patient factors may have contributed to the event. There was no evidence to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time. This is an initial/final mdr report.
Patient Sequence No: 1, Text Type: N, H10
[56352439]
In the literature article "transcatheter arterial embolization with n-butyl cyanoacrylate for the treatment of acquired uterine vascular malformations" by picel a. C. ; koo s. J. ; roberts a. C, published in cardiovascular and interventional radiology. 39 (8) (pp 1170-1176), a patient (patient 4) experienced persistent avm on ultrasound 291 days after left uterine artery embolization with nbca (3ml of 1:2 and 1:1. 5 mixture). The catalog/lot number of the nbca was not provided in the article. The avm was initially discovered via routine untrasound approximately 4 years after fibroid resection. Nbca was used to embolize the left uterine artery, but the avm was seen to be persistent on ultrasound. Eight months later, repeat treatment was provided with bilateral uterine artery embolization with nbca (1ml of 1:4 and 3ml of 1:9 mixtures). The avm was improved, but persistent. The patient had a normal intra-uterine pregnancy approximately 2 years after treatment. No further patient, procedure or device information was provided. The purpose of the study was to evaluate the technique and outcomes of trans-catheter arterial embolization (tae) with n-butyl cyanoacrylate (nbca) for the treatment of acquired uterine arteriovenous malformations (avms). Embolization resulted in angiographic stasis of flow in all seven procedures. There were no major complications. Three of the five women treated had pregnancies and deliveries after embolization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2016-00145 |
| MDR Report Key | 5996123 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2016-10-04 |
| Date of Report | 2016-09-16 |
| Date of Event | 2016-08-01 |
| Date Mfgr Received | 2016-09-16 |
| Date Added to Maude | 2016-10-04 |
| 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 | 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 2 |
| Generic Name | TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS |
| Product Code | KGG |
| Date Received | 2016-10-04 |
| 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. Required No Informationntervention | 2016-10-04 |