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 2016-04-12 for UNK-CNV_NBCA manufactured by Codman And Shurtleff, Inc.
[42418997]
This is one of one initial/final mdr reports being submitted for this literature complaint. The literature article is attached to the report. Unknown part number and unknown lot number; all three attempts to obtain product information were unsuccessful, udi is unavailable. Reynolds m. R; arias e. J; chatterjee a. R. ; chicoine m. R. ; cross d. T. (2015, oct 1); acute rupture of a feeding artery aneurysm after embolization of a brain arteriovenous malformation; interventional neuroradiology , vol. 21(5) 613? 619. The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown. The investigation could not be completed; no conclusion could be drawn, as no product was received.
Patient Sequence No: 1, Text Type: N, H10
[42418998]
In the literature article "acute rupture of a feeding artery aneurysm after embolization of a brain arteriovenous malformation" by reynolds, matthew r, eric j arias, arindam r chatterjee, michael r chicoine and dewitte t cross iii, published interventional neuroradiology 2015, vol. 21(5) 613 -619, it was reported that a (b)(6) year-old female patient underwent staged treatment of a large arteriovenous malformation (avm) and post operatively suffered rupture of an middle cerebral artery (mca) aneurysm. Per the article: "a (b)(6)-year-old female presented with headache and mild left hemiparesis referable to a 5 cm right frontoparieto- temporal avm with surrounding vasogenic edema. The avm was associated with numerous bilateral feeding artery aneurysms (the largest was a 2 cm right mca bifurcation aneurysm). There was also a large, partially thrombosed venous varix. Staged embolization of the avm was performed. Several hours after the third stage of her embolization, she became obtunded, with a fixed and dilated right pupil. Head computed tomography (ct) showed a large intraparenchymal hemorrhage with midline shift in the right sylvian fissure, remote from the avm nidus. She was taken to surgery for a decompressive craniectomy and hematoma evacuation. The mca aneurysm was confirmed to be the source of hemorrhage and it was clipped. Despite aggressive medical and surgical treatments, the patient died. " the first stage of the treatment involved nbca glue and there were no reported issues after the first intervention. The second intervention was done with a non-codman embolic material and no complications were reported. The third intervention was also done with a non-codman embolic material; however, a large cerebral hemorrhage was noted secondary to rupture of an mca aneurysm with subsequent death noted. The nbca glue cannot be dissociated from the event. At the time of complaint entry no device specific information, i. E. Catalogue/lot number, is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226348-2016-00055 |
| MDR Report Key | 5570106 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2016-04-12 |
| Date of Report | 2016-03-25 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2016-03-25 |
| Date Added to Maude | 2016-04-12 |
| 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 DRIVE |
| 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 |
| Generic Name | TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS |
| Product Code | KGG |
| Date Received | 2016-04-12 |
| 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. Death; 2. Hospitalization; 3. Required No Informationntervention | 2016-04-12 |