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.
[79272604]
Article attached to this mdr: wakhloo, a. K. , perlow, a. , linfante, i. Et al. (2005). Transvenous n-butyl-cyanoacrylate infusion for complex dural carotid cavernous fistulas: technical considerations and clinical outcome. Ajnr am j neuroradiol 26:1888? 1897, september 2005. 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, patient/procedural factors may have contributed to the event. 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.
Patient Sequence No: 1, Text Type: N, H10
[79272605]
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, embolization of n-bca (catalog/lot not listed in article) into the mca was reported. A (b)(6) female patient (patient 1) had presented with symptoms of chemosis and proptosis. Patient had a type d dural cavernous carotid fistula (dccf). Access via the percutaneous superior ophthalmic vein (sov) inferior petrosal sinus (ips) and internal maxillary artery was made. Embolization was performed using nbca (tv) and pva (imax). The initial ips approach failed in the patient, and a cannulation of the sov through the external jugular-facial vein could not be performed, because of a tight stenosis of the sov at the carotid sinus (cs) junction. In a second attempt, the posterior part of the fistula was occluded through the ips by using n-bca infusion. Subsequently, residual feeders off the middle meningeal artery were embolized with pva particles in an attempt to obliterate the anterior component; however, obliteration could not be achieved. A direct access of the sov via the facial vein was attempted, but failed. Residual filling of the fistula with drainage to the narrowed sov was present. A successful direct sov puncture was performed and the cs catheterized. The remnant anterior part of the cs was then obliterated with n-bca. A single n-bca droplet was flushed through forceful injection via fistulas into the ica and subsequently into the distal middle cerebral artery (mca) territory without any clinical sequelae. Glue was noted to have adhered to the wall of the m4 segment of the mca, which remained patent but slightly narrowed. The patient was kept on aspirin and plavix (clopidogrel) for 6 weeks. A 6-month follow-up angiography showed obliterated dccf and a patent mca branch. The patient has been asymptomatic now for >3 years. 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 | 1226348-2017-00103 |
| MDR Report Key | 6692968 |
| 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. Required No Informationntervention | 2017-07-07 |