MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-09-14 for NBCA LIQUID EMBOLIC SYSTEM 2 631500 manufactured by Cordis Neurovascular, Inc..
[3114703]
Information was received reporting the death of a patient after off-label use of two enterprise vrd stents and nbca glue. The procedure was coiling of a 5 mm x 3. 5 mm left a1/a2 junction aneurysm with a 2. 5mm neck. An unknown balloon used for aneurysm neck remodeling ruptured the parent vessel during initial inflation. The event was treated with coiling and with off-label use of nbca glue in an attempt to occlude the parent vessel. Some of the glue migrated into the left middle cerebral (mca). In order to preserve perfusion to the left middle cerebral, two enterprise vrds ((b)(4) 4. 5 mm x 37 mm lot#10086766 and (b)(4) 4. 5 mm x 28 mm lot# 10076830) were implanted in overlapping fashion from the m2 to supraclinoid segment. The stents were placed within the intended target area without complications. This resulted in better filling of the left mca; however, there was some patchy capillary blush within the mca, likely from small emboli from the injection of glue used to try and occlude the parent artery. Once there was control of the vessel a ventriculostomy was placed. Ct scan demonstrated interval development of an area of infarction within the left frontal lobe and some possibly low attenuation within the left basal ganglia. There was no evidence of herniation. Post procedurally the patient was admitted to the neuro icu and was then made a dnr with withdrawal of life support and initiation of comfort measures only. The patient died seven days post procedure. Additionally it was noted that with initial angiography of the left internal carotid artery there was minimal spasm around the 6fr codman mpc guide catheter which was treated with intra-arterial injection of nicardipine.
Patient Sequence No: 1, Text Type: D, B5
[10141150]
Review of lot 229917 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. No non-conformances records or excursions were issued for this lot 229917. This is one of multiple products involved with this adverse event, which is associated with mfg report 1058196-2012-00354 and 9616099-2012-00498. Additional information will be submitted within 30 days of receipt.
Patient Sequence No: 1, Text Type: N, H10
[10184308]
Please note that the actual product catalog and lot number are unknown, therefore the product captured represents an unknown nbca liquid embolic kit. Also, please note that there is no code available for glue as a device. Coil, balloon, enterprise, catheter, microcatheter. The product will not be returned for analysis, and additional information will be submitted within 30 days of receipt. This is one of multiple products involved with this adverse event, which is associated with mfg report 1058196-2012-00354 and 9616099-2012-00498.
Patient Sequence No: 1, Text Type: N, H10
[19784815]
Information was received reporting there was migration and small emboli with an area of infarction from the injection of trufill nbca ((b)(4)/lot 229917) which was used off-label in an attempt to emergently occlude the parent vessel after it ruptured with inflation of a balloon during coil embolization in the anterior cerebral artery circulation. Additionally, it was noted that with initial angiography of the left internal carotid artery there was minimal spasm around the 6fr envoy mpc guiding catheter ((b)(4)/lot 15584708) which was treated with intra-arterial injection of nicardipine. The partial occlusion of the middle cerebral artery (mca) from glue embolus was treated with off-label use of two overlapping enterprise vrd which resulted in better mca filling. Once there was control of the anterior cerebral artery bleeding which had been ruptured by the balloon, a ventriculostomy was placed. The patient was admitted to the neuro icu and was then made a dnr with withdrawal of life support and initiation of comfort measures only. The patient died seven days post procedure. The procedure was coiling of a 5 mm x 3. 5 mm left a1/a2 junction aneurysm with a 2. 5 mm neck. Initially the aneurysm was going to be coiled while using a microvention sceptor c balloon for neck remodeling. Upon inflation of the sceptor c balloon, the balloon did not inflate as intended and caused the a1/a2 segment to perforate. The event was treated with coiling and with off-label use of nbca glue in an attempt to occlude the parent vessel. Some of the glue migrated into the left middle cerebral (mca). In order to preserve perfusion to the left middle cerebral, two enterprise vrds were used off-label and implanted in overlapping fashion from the m2 to supraclinoid segment. The stents were placed within the intended target area without complications. This resulted in better filling of the left mca; however, there was some patchy capillary blush within the mca, likely from small emboli from the injection of glue used to try and occlude the parent artery. Once there was control of the vessel a ventriculostomy was placed. Ct scan demonstrated interval development of an area of infarction within the left frontal lobe and some possibly low attenuation within the left basal ganglia. There was no evidence of herniation. Additionally with review of the reported information, it was noted that with initial angiography of the left internal carotid artery there was minimal spasm around the 6fr codman mpc guide catheter which was treated with intra-arterial injection of nicardipine. Post procedurally the patient was admitted to the neuro icu and was then made a dnr with withdrawal of life support and initiation of comfort measures only. The patient died seven days post procedure. A review of the manufacturing documentation associated with this trufill nbca liquid embolic system lot presented no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint. The trufill n-bca liquid embolic system is indicated for the embolization of cerebral arteriovenous malformations (avms) when pre-surgical devascularization is desired. Incorrect vessel occlusion, stroke and death are known complications associated with the use of trufill nbca as outlined in the instructions for use. The instructions for use outlines that recommended ratios of trufill n-bca to trufill ethiodized oil and trufill tantalum powder vary depending on the location of injection (feeding pedicle or intranidal), the diameters of the pedicle and nidal component supplied, tortuosity/linearity of the pedicle, presence of av fistulae, and flow rates. Therapeutic embolization should not be performed when high blood flow precludes the safe infusion of embolic agent. It is further warned that polymerization time, viscosity, and injection technique are interrelated and affect the progress of the embolization. The appropriate formulation of any additives is dependent upon the expert evaluation of the relationship of anatomy, hemodynamics, and the catheter system. It is outlined that the infusion catheter should be positioned as close as possible to the treatment site in order to avoid inadvertent occlusion of normal vessel and that its use is contraindicated when optimal catheter placement is not possible. Clinical/procedural factors including off-label use, catheter position, ratio of the components of the nbca embolic system used, and flow characteristics of the treatment site are factors that may have contributed to the emboli. With review of the available information and device history records review there is no indication of any device manufacturing, design or performance issues associated with the reported events. Therefore, no corrective actions will be taken at this time. This is one of multiple products involved with this adverse event, which is associated with mfg report 1058196-2012-00354 and 9616099-2012-00498.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1058196-2012-00354 |
| MDR Report Key | 2745099 |
| Report Source | 05,06,07 |
| Date Received | 2012-09-14 |
| Date of Report | 2012-08-24 |
| Date of Event | 2012-08-20 |
| Date Mfgr Received | 2012-10-18 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2012-09-14 |
| 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 330142802 |
| Manufacturer Country | US |
| Manufacturer Postal | 330142802 |
| Manufacturer Phone | 5088283106 |
| Manufacturer G1 | CODMAN AND SHURTLEFF, INC |
| Manufacturer Street | 14700 NW 57TH COURT |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NBCA LIQUID EMBOLIC SYSTEM 2 |
| Generic Name | CNV_NBCA (MFE) |
| Product Code | KGG |
| Date Received | 2012-09-14 |
| Model Number | NA |
| Catalog Number | 631500 |
| Lot Number | 229917 |
| ID Number | NA |
| Device Expiration Date | 2013-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 0 | 1. Death | 2012-09-14 |