MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-07-05 for UNK-CNV_NBCA manufactured by Codman And Shurtleff, Inc.
[48717323]
This is one of one initial/final mdr report being submitted for this complaint. Udi: unknown part number, all 3 attempts to obtain product were unsuccessful, udi is unavailable. Concomitant products: 5 fr envoy catheter (codman); 1. 2 fr magic microcatheter (balt extrusion, (b)(4)). Mascitelli j. R , mcneill i. T. , mocco j. ,berenstein a. , demattia j. , fifi j. T. (2015, may 06); ruptured distal aica pseudoaneurysm presenting years after vestibular schwannoma resection and radiation; j neurointervent surg 2016;8:e19. (b)(4). The product was not available for analysis. A device history record (dhr) review could not be conducted as the lot number was not provided/known. Stroke and neurologic deficits, in this case specifically; hydrocephalus, are known potential adverse events associated with the use of the nbca trufill product and are listed in the ifu as such. Although there is not product specific information available, all products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint. Review of the available information suggests that underlying disease process and target lesion anatomical characteristics may have contributed to the reported events.
Patient Sequence No: 1, Text Type: N, H10
[48717324]
In the literature article? Ruptured distal aica pseudoaneurysm presenting years after vestibular schwannoma resection and radiation. By justin r mascitelli, ian t mcneill, j mocco, alejandro berenstein, joseph demattia, johanna t fifi. Published: j neurointervent surg 2016;8:e19. , it was reported that the patient presented with a hunt? Hess grade ii subarachnoid hemorrhage (sah) which was treated with endovascular parent vessel occlusion(pvo) using truefill nbca. Given that the pseudoaneurysm arose distal to brainstem perforators and there was a well sized right-sided posterior inferior cerebellar artery (pica) and superior cerebellar artery (sca), the decision was made to perform a pvo of the rostral branch of the right anterior inferior cerebellar artery (aica) at the level of the pseudoaneurysm using trufill nbca (codman neurovascular). Control angiography following the pvo demonstrated complete obliteration of the pseudoaneurysm as well as patency of the proximal portion and caudal branch of the anterior inferior cerebellar artery. The patient tolerated the procedure well and woke without any new neurological deficits. Over the following 24? 48 h, he developed worsening headache and communicating hydrocephalus, requiring placement of a right frontal external ventricular drain. A follow-up ct head 10 days after intervention demonstrated, a right cerebellar and brachium pontis stroke. The patient did not undergo mri. He ultimately required placement of a right frontal ventriculo-paritoneal shunt. He had a short stay in acute rehabilitation and is now doing well at home. 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 | 1226348-2016-00114 |
| MDR Report Key | 5768572 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-07-05 |
| Date of Report | 2016-06-17 |
| Date of Event | 2015-05-06 |
| Date Mfgr Received | 2016-06-17 |
| Date Added to Maude | 2016-07-05 |
| 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 |
| Generic Name | TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS |
| Product Code | KGG |
| Date Received | 2016-07-05 |
| 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 | 2016-07-05 |