MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,03,05,07 report with the FDA on 2013-07-17 for NBCA LIQUID EMBOLIC KIT 631XXX manufactured by Cordis Neurovascular, Inc..
[3653909]
Marine, l. , et al? Glue embolus complicating the endovascular treatment of a patient with loeys-dietz syndrome? , j. Vascsurg 2010;52:1350-3 report that nbca glue embolized to the brachial artery during off label use of nbca glue to fill a subclavian pseudoaneurysm while using an opta angioplasty to cover the neck. A vein bypass was required and the patient was discharged asymptomatic with a palpable radial pulse. The patient was diagnosed with loeys-dietz syndrome and presented with a symptomatic 2. 6 cm subclavian pseudoaneurysm. Extensive staged coil embolization of proximal left subclavian branches including the vertebral, internal mammary, and thyrocervical trunk arteries was also required to insure against pseudoaneurysm enlargement or rupture secondary to a type ii endoleak. Catheter directed nbca sac embolization was done for complete ablation of the pseudoaneurysm sac and any remnant small branches. An 8mmx4cm opta balloon angioplasty catheter was inflated to cover the neck of the aneurysm during nbca embolization. The glue was diluted 1:1 and instilled via a coaxial mc with a total of 1. 5ml instilled. During deflation of the balloon, a small amount of glue debris was noted going down the subclavian artery to the brachial artery. The brachial artery was immediately clamped with sheath removal and a 10mmx5cm viabahn stent graft was deployed excluding the left subclavia.
Patient Sequence No: 1, Text Type: D, B5
[10965682]
The product was not returned and there was no sterile lot number information reported thus no dhr maybe performed. Additional information will be submitted within 30 days of receipt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1058196-2013-00188 |
| MDR Report Key | 3231131 |
| Report Source | 01,03,05,07 |
| Date Received | 2013-07-17 |
| Date of Report | 2013-06-25 |
| Date of Event | 2010-05-10 |
| Date Mfgr Received | 2013-06-25 |
| Date Added to Maude | 2013-07-17 |
| 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 | MR. MATTHEW KING |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN AND SHURTLEFF, INC |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| 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 | 2013-07-17 |
| Model Number | NA |
| Catalog Number | 631XXX |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 8 | 1. Life Threatening | 2013-07-17 |