MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05,07 report with the FDA on 2012-03-02 for NBCA LIQUID EMBOLIC KIT 631XXX manufactured by Cordis Neurovascular, Inc..
[2522975]
During a literature search the following article was found: journal of neurointerventional surgery march 2011 3 (1) (pp 21-24) 'vascular inflammation with eosinophils after the use of n-butyl cyanoacrylate liquid embolic system', quinn j. C. , mittal n. , baisre a. , cho e. S. , sharer l. R. , candhi c. , prestigiacoma c. J. The article reported three cases of restricted eosinophilic vasculitis secondary to nbca sensitization. With follow-up investigation it was reported by the contact author that the brand used was trufill nbca. Additionally it was reported that among the 158 cases that were reviewed although it was not clearly stated in the article, there was a secondary bleeding/intracranial hemorrhage not related to eosinophilia, but was most likely procedure related.
Patient Sequence No: 1, Text Type: D, B5
[9609611]
Objective and importance: currently, n-butyl cyanoacrylate (n-bca) is one of the most widely used liquid embolic agents in the treatment of intracranial arteriovenous malformations (avms). The cases of three patients are reported who underwent endovascular embolization with n-bca, followed by resection in two and post-embolization hemorrhage with emergent evacuation in one, with histologic demonstration of an eosinophilic vasculitis found in resected avm specimens. This is probably the first report of this tissue reaction, which may have theoretically serious clinical implications. Clinical presentation: in this series, three patients (2 women, 1 man) presented with intracranial avms (spetzler-martin i-iii) with the lesions located in the frontal lobe in two of the patients and in the parietal lobe in one. All patients presented with headache, and one also had new-onset seizures. Intervention: all patients underwent embolization with n-bca before a planned, staged surgical resection of the embolized avms. One patient had four embolizations over a 5-month period, one had three embolizations over 3 months complicated by hemorrhage after embolization requiring emergent evacuation of the hematoma, and the third patient had a single embolization. In all three patients, surgical and autopsy specimens showed an inflammatory response within the embolized vasculature with a prominent eosinophilic infiltrate. Conclusion: the eosinophilic vasculitis seen in the pathology specimens may represent a previously undocumented hypersensitivity reaction following exposure to n-bca, with the potential for adverse sequelae, including increased risk of hemorrhage as was seen in one of our patients. (b)(4). All rights reserved. The product is not available for evaluation and testing. Additional information will be submitted within 30 days upon receipt. This is one of four products reported in the same journal article/literature search. Please reference mfr. Report # 1058196-2012-00101; # 1058196-2012-00102; # 1058196-2012-00103; and # 1058196-2012-00104.
Patient Sequence No: 1, Text Type: N, H10
[9954371]
Please note that the product catalog number was corrected. Journal of neurointerventional surgery march 2011 3 (1) (pp 21-24) "vascular inflammation with eosinophils after the use of n-butyl cyanoacrylate liquid embolic system", quinn j. C. , mittal n. , baisre a. , cho e. S. , sharer l. R. , candhi c. , prestigiacoma c. J. Reported three cases of restricted eosinophilic vasculitis secondary to nbca sensitization. With follow-up investigation it was reported by the contact author that the brand used was trufill nbca. Additionally it was reported that among the 158 cases that were reviewed although it was not clearly stated in the article, there was a second bleeding not related to eosinophilia, but was most likely procedure related. No further information has been obtained regarding this case in response to multiple investigative efforts. The product was not returned for inspection. The lot number of the nbca is not known; therefore, a device history record review cannot be completed. These procedures are performed in vessels with existing abnormalities. The instructions for use outlines that the adverse event of hemorrhage may be associated with embolization procedures (including those observed during the clinical study), and may occur at any time during or after the procedure. Due to the lack of procedural information the relationship of the nbca to the reported procedural related bleeding and root cause or contributing factors cannot be determined. Therefore, no corrective actions will be taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1058196-2012-00101 |
| MDR Report Key | 2475709 |
| Report Source | 03,05,07 |
| Date Received | 2012-03-02 |
| Date of Report | 2012-02-20 |
| Date of Event | 2012-02-02 |
| Date Mfgr Received | 2012-04-16 |
| Date Added to Maude | 2012-03-02 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. LINA ALZATE |
| Manufacturer City | MIAMI LAKES FL 330142802 |
| Manufacturer Country | US |
| Manufacturer Postal | 330142802 |
| Manufacturer Phone | 7863136492 |
| Manufacturer G1 | CORDIS NEUROVASCULAR, INC. |
| Manufacturer Street | 14700 NW 57TH COURT |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NBCA LIQUID EMBOLIC KIT |
| Generic Name | CNV_NBCA (MFE) |
| Product Code | KGG |
| Date Received | 2012-03-02 |
| Model Number | NA |
| Catalog Number | 631XXX |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS NEUROVASCULAR, INC. |
| Manufacturer Address | 14700 NW 57TH COURT MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-03-02 |