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 2012-07-05 for NBCA LIQUID EMBOLIC KIT 631XXX manufactured by Cordis Neurovascular, Inc..
[2703262]
It was reported that an enterprise (catalog and lot unknown) was used off label in attempt to open a middle cerebral artery that was occluding due to nbca. The end result was the patient had a large ischemic stroke and later died. It was indicated that the death or use of the stent did not directly caused the death or stroke. Instead, it was the nbca that caused the stroke and the sequelae of the stroke led to the death.
Patient Sequence No: 1, Text Type: D, B5
[9972803]
The catalog and lot number for the device was not provided, therefore the device noted ((b)(4)), represents a nbca liquid embolic kit that the catalog number begins with 631. . The product will not be returned for analysis, and additional information will be submitted within 30 days of receipt. This is one of two products involved with this adverse event, which is associated with mfg report 1058196-2012-00249 and 1058196-2012-00250.
Patient Sequence No: 1, Text Type: N, H10
[10050764]
During an annual review of enterprise cases, the reporter noted a case in which the enterprise vrd (catalog and lot unknown) was used off label in attempt to open a middle cerebral artery that was occluding due to nbca. The end result was that the patient had a large ischemic stroke and later died. It was indicated that the use of the stent did not directly caused the death or stroke. Instead, it was the nbca that caused the stroke and the sequelae of the stroke led to the death. In response to follow-up investigation it was reported that during the attempted embolization of the avm, the nbca ended up "migrating" into the main trunk of the middle cerebral artery. There was a large mca stroke with midline shift that worsened. There is no further information regarding the nbca procedure or the procedure. The lot number of the enterprise vrd is not known; therefore a device history record review cannot be performed. As outlined in the ifu, the indicated use of the enterprise vrd is to prevent coils from protruding out of the aneurysm into the parent artery. Due to the limited information, a definitive conclusion cannot be made; however, based on the reported information that the enterprise was being used off-label to treat cerebral artery occlusion caused by nbca and that the enterprise stent did not directly cause the death or stroke, there is no indication of any device performance or manufacturing issues related to the use of the enterprise vrd. Therefore, no corrective actions will be taken at this time. The specific nbca product and lot number used in the procedure is not known; therefore, a device history record review cannot be completed. 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. Due to the lack of information regarding the use of the nbca to treat an avm, no conclusion can be made regarding the reported migration of the nbca and subsequent stroke and sequelae. It is possible that clinical/procedural factors including catheter position, ratio of the components of the nbca embolic system used, and flow characteristics of the treatment site contributed to the event. Therefore, no corrective actions will be taken at this time. This is one of two products involved with this adverse event, which is associated with mfg report 1058196-2012-00249 and 1058196-2012-00250.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1058196-2012-00250 |
| MDR Report Key | 2640185 |
| Report Source | 05,06,07 |
| Date Received | 2012-07-05 |
| Date of Report | 2012-06-20 |
| Date of Event | 2011-08-09 |
| Date Mfgr Received | 2012-07-16 |
| Date Added to Maude | 2012-07-05 |
| 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 | 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 KIT |
| Generic Name | CNV_NBCA (MFE) |
| Product Code | KGG |
| Date Received | 2012-07-05 |
| Model Number | NA |
| Catalog Number | 631XXX |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 2012-07-05 |