MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2017-10-13 for NBCA LIQUID EMBOLIC KIT UNK manufactured by Codman And Shurtleff, Inc.
[89294942]
(b)(6). This mdr is from a literature article and describes 2 patients. There was no specific patient, device or procedure information provided. 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. Article attached to the mdr: yang r. Y, tan, k. T. , beecrift, j. R, et al, (2017). Direct sac puncture versus transarterial embolization of type ii endoleaks: an evaluation and comparison of outcomes, vascular 2017, vol. 25(3) 227? 233 doi: 10. 1177/1708538116663992. Three attempts to obtain additional information from the author were unsuccessful. Date of event, product code, and lot number could not be obtained from the author. Udi: unknown part number, attempts to obtain product part number were unsuccessful, udi unavailable. Conclusion: the devices were not available for analysis. In addition, the lot number could not be obtained; therefore, a dhr review could not be performed. Passage of embolic material into normal vessels adjacent to the lesion is a known adverse event associated with embolization procedures and is listed in the instructions for use (ifu). The trufill n-bca liquid embolic system is indicated for the embolization of cerebral arteriovenous malformations (avms) when pre-surgical devascularization is desired. The ifu cautions that? High blood flow precludes safe infusion of an embolic agent?. There is no current safety signal identified related to the reported event based on review of complaint history for the device. Since there was no evidence to suggest the event was 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
[89294943]
In the literature article? Direct sac puncture versus transarterial embolization of type ii endoleaks: an evaluation and comparison of outcomes? By yang r. Y, tan, k. T. , beecrift, j. R, et al, published vascular 2017, vol. 25(3) 227? 233 doi: 10. 1177/1708538116663992, it was reported that two patients had unintentional glue embolizations without consequences during treatment of type ii endoleaks with trufill nbca embolization glue (catalog and lot numbers not provided). Per the article, the purpose of the retrospective was to determine the outcomes of type ii endoleak embolization with aneurysm sac obliteration and whether the approach? Direct sac puncture or transarterial? Affects outcome. It was reported that two patients had small non-target glue embolizations with no consequence. There was no patient, device or procedure specific data reported for these two events. A review of patients who underwent endovascular aneurysm repairs and subsequent type ii endooleaks embolization over 10 years was performed. In total, 23 patients (83% male, 17 % female) and 35 3 embolization procedures were examined. The median age was 76 years. The exact embolization technique was individualized to the patient? S anatomy and endoleak configuration, at the discretion of the radiologist. Embolization materials used included trufill ncba glue, platinum microcoils (micronester, cook medical, (b)(4)), particulate embolic materials (embosphere, merit medical, (b)(4)), amplatzertm vascular plug (st. Jude medical, (b)(4)), and gelatin sponge slurry. For glue embolizations, nbca glue and lipiodol mixture were used (1:3? 1:4 glue:lipiodol ratio, at the discretion of the radiologist based on flow dynamics in the aneurysm sac).
Patient Sequence No: 1, Text Type: D, B5
[110615568]
This mdr is submitted to correct the mfr site contact name and email address.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2017-00170 |
| MDR Report Key | 6947132 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2017-10-13 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-01-01 |
| Date Mfgr Received | 2017-10-17 |
| Date Added to Maude | 2017-10-13 |
| 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 | JOAQUIN KURZ |
| Manufacturer Street | 325 PARAMOUNT DR |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 9497899383 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NBCA LIQUID EMBOLIC KIT |
| Generic Name | TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS |
| Product Code | KGG |
| Date Received | 2017-10-13 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Life Threatening | 2017-10-13 |