MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2017-06-28 for NBCA LIQUID EMBOLIC SYSTEM UNK-CNV_NBCA manufactured by Codman And Shurtleff, Inc.
[78595634]
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 kirschen, m. P. , dori, y. , itkin, m. , et al. (2016) cerebral lipiodol embolism after lymphatic embolization for plastic bronchitis. Pediatr 2016;176:200-3 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 device was not available for analysis. In addition, no lot number could be obtained; therefore, a dhr could not be performed for the devices. Neurological deficits, passage of embolic material into normal vessels adjacent to the lesion, and seizure are known adverse events that can occur during or after embolization procedures. The trufill n-bca liquid embolic system is indicated for the embolization of cerebral arteriovenous malformations (avms) when pre-surgical devascularization is desired. Based on the information provided in the article, procedural factors may have contributed to the event. 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
[78595635]
In the literature article? Cerebral lipiodol embolism after lymphatic embolization for plastic bronchitis? By matthew p. Kirschen, yoav dori, maxim itkin, daniel j. Licht, rebecca ichord, and arastoo vossough, published pediatr 2016;176:200-3, it was reported that post-lymphatic procedure using trufill glue, cerebral lipiodol embolization was reported in patient due to direct shunting between the lymphatic channels and the pulmonary veins. A (b)(6) boy with pulmonary atresia with intact ventricular septum developed plastic bronchitis from worsening right heart dysfunction and elevated central venous pressure. His treatment included prednisone, inhaled tissue plasminogen activator, and sildenafil with limited success. He underwent lymphatic duct embolization with resolution of symptoms, but these recurred after surgery for pulmonary valve replacement. Consequently, he presented again for lymphatic embolization. Repeat dynamic contrast lymphangiography demonstrated abnormal peri bronchial lymphatic ducts on the right side. Intranodal lymphangiogram was performed to opacify a target central lymphatic vessel. Access to this vessel was then performed with a 22-gauge chiba needle (cook medical inc, (b)(4)) via a transabdominal approach. A v18 control guide wire (boston scientific, (b)(4)) was advanced into the lymphatic duct and manipulated cephalad. Over the wire, a 60-cm2. 3 f rapid transit microcatheter (catalog and lot number no provided in article) was advanced further into the duct for imaging of the duct and its branches. Embolization of the lymphatic ducts was performed with 1-2 ml of lipiodol and 1 ml of n-butyl cyanoacrylate (trufill glue, catalog and lot numbers not provided). During the procedure, an abnormal connection between a lymphatic duct and the pulmonary vein was seen. There were no intraprocedural complications, and the patient had a normal neurologic examination on recovery from anesthesia. Approximately 5 hours after the procedure, the patient became acutely unresponsive and had a seizure with rightward gaze deviation, lip smacking, and stiffness of the left lower extremity. The seizure lasted less than 3 minutes and was aborted with lorazepam. No further anticonvulsants were required. A head computed tomography (ct) scan showed innumerable hyperdensities bilaterally throughout the supra- and infratentorial brain. The hyperdensities demonstrated spectral characteristics consistent with iodine on dual energy imaging, indicating that they were iodine-based (lipiodol) rather than primarily multifocal hemorrhage. The patient? S mental status improved during the next several hours, although he had persistent difficulties with speech, impaired vision, and a right-sided hemiparesis. A ct scan done 5 days later showed interval improvement in the hyperdensities. A brain magnetic resonance scan at 8 days showed multiple areas of t2/fluid-attenuated inversion recovery hyperintense signal abnormality. There were punctate foci of susceptibility within these areas, and a few small residual foci of mild restricted diffusion. The child? S neurologic deficits gradually improved during the next week with rehabilitation therapies and had completely resolved by hospital discharge. No further device, procedure or patient specific information was provided in the article and no additional information could be obtained from the author.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2017-00080 |
| MDR Report Key | 6673634 |
| Report Source | LITERATURE |
| Date Received | 2017-06-28 |
| Date of Report | 2017-06-08 |
| Date of Event | 2016-05-11 |
| Date Mfgr Received | 2017-06-08 |
| Date Added to Maude | 2017-06-28 |
| 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 | 2017-06-28 |
| 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. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2017-06-28 |