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 2013-05-02 for NBCA LIQUID EMBOLIC KIT 631XXX manufactured by Cordis Neurovascular, Inc..
[3159628]
The complaint received states that during right carotid artery occlusion, there was unknown nbca liquid embolic kit distal embolisation with subsequent cerebral infarction and death. The treatment for the leakage was to place coils in the target rica site and then inject the nbca into the coil mass to stop the leaking. Initial coil placement was performed with multiple cordis coils. Post coil placement and glue injection, angiography noted distal embolization of nbca glue into the right middle cerebral artery distribution. Secondary coil placement was performed with multiple coils and complete occlusion was noted. Significant stroke and subsequent death were reported post procedure.
Patient Sequence No: 1, Text Type: D, B5
[10830453]
After initial coil placement, angiography revealed distal flow past the implanted coils. The patient's date of death was three years after, exact date not known. The patient had a long complicated course before and after the procedure. He had failed a full dose of chemotherapy and radiation therapy at another academic institution (tumor had progressed despite treatment) and came to another facility for a second opinion after being offered palliative care. He was offered "re-irradiation" or a second full dose of radiation therapy. It's a somewhat investigational treatment. He has lots of follow up records from many hospitals, including a subsequent bleed from his right external carotid artery. The product remains implanted, thus is unavailable for analysis; further, no sterile lot number information is available and no dhr can be performed. Catalogue number 631xxx is being used because the actual catalogue number is unavailable. Embolisation is a known potential adverse event associated with liquid glue assisted procedures and is listed in the ifu as such. All products undergo a 100% inspection prior to release for use, there is no evidence of manufacturing issues that may have contributed to the reported event; therefore, no corrective action is required at this time. Review of the limited information suggests that procedural and anatomic issues may have contributed to the reported events. Add'l medical devices: 5f weinberg catheter, meditech occlusion balloon catheter, prowler 14 microcatheter.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1058196-2013-00115 |
| MDR Report Key | 3090754 |
| Report Source | 05,06,07 |
| Date Received | 2013-05-02 |
| Date of Report | 2013-04-06 |
| Date of Event | 2006-08-09 |
| Date Mfgr Received | 2013-04-06 |
| Date Added to Maude | 2013-05-03 |
| 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 Country | US |
| 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 | 2013-05-02 |
| 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 | 0 | 1. Death; 2. Life Threatening | 2013-05-02 |