MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-07 for AXXENT FLEXISHIELD MINI (K090417) manufactured by Xoft, Inc..
[1816026]
Early stage breast cancer (pt1b). Pt was treated on (b)(6) 2010 with left segmental resection, sentinel lymph node (sln) mapping, sln dissection, and intraoperative radiation therapy followed by left breast reconstruction, right mastoplexy for symmetry and removal and replacement of bilateral implants. Pt's 6 month follow-up mammogram on (b)(6) 2010 findings reported "innumerable, new high density presumed calcifications seen scattered in the left (treated) breast. " mri of the breast on (b)(6) 2010 showed "numerous punctate foci of magnetic susceptibility within the skin, along the implant capsule and within the breast parenchyma are predominately distributed with the postsurgical bed and along the surgical incision sites. These likely are artifact from metallic debris. " on (b)(6) 2010, a core biopsy was performed. The (b)(6) 2011, pathology report "confirms the presence of high density, punctate material within several of the core specimens. " this report is being filed with fda due to the findings of the 6 month pt follow-up completed on (b)(6) 2011. The pt has not experienced any adverse events or untoward effects to date.
Patient Sequence No: 1, Text Type: D, B5
[18372387]
Follow-up to report dated 01/06/2011.
Patient Sequence No: 1, Text Type: D, B5
[6321376]
Follow-up to report of 01/07/2011 on pt (b)(6) (#1); 3 additional pts have had mammography imaging show similar results of "innumerable punctate metallic densities... Felt to be artifactual and apparently are debris left from the tungsten shield placed at the time of intraoperative radiation therapy" establishing a pattern. No further pts have or will be treated with the flexishield at this facility. It is anticipated that subsequent imaging on 23 additional pts (n=27 total) will have similar results on imaging. No adverse events or untoward effects have been reported to date.
Patient Sequence No: 2, Text Type: D, B5
[6320007]
Follow-up to report of 01/07/2011 on pt (b)(6) (#1); 3 additional pts have had mammography imaging show similar results of "innumerable punctate metallic densities... Felt to be artifactual and apparently are debris left from the tungsten shield placed at the time of intraoperative radiation therapy" establishing a pattern. No further pts have or will be treated with the flexishield at this facility. It is anticipated that subsequent imaging on 23 additional pts (n=27 total) will have similar results on imaging. No adverse events or untoward effects have been reported to date.
Patient Sequence No: 3, Text Type: D, B5
[6316594]
Follow-up to report of 01/07/2011 on pt (b)(6) (#1); 3 additional pts have had mammography imaging show similar results of "innumerable punctate metallic densities... Felt to be artifactual and apparently are debris left from the tungsten shield placed at the time of intraoperative radiation therapy" establishing a pattern. No further pts have or will be treated with the flexishield at this facility. It is anticipated that subsequent imaging on 23 additional pts (n=27 total) will have similar results on imaging. No adverse events or untoward effects have been reported to date.
Patient Sequence No: 4, Text Type: D, B5
| Report Number | MW5018936 |
| MDR Report Key | 1959775 |
| Date Received | 2011-01-07 |
| Date of Report | 2011-01-06 |
| Date of Event | 2010-06-24 |
| Date Added to Maude | 2011-01-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXXENT FLEXISHIELD MINI (K090417) |
| Generic Name | FLEXISHIELD |
| Product Code | IXI |
| Date Received | 2011-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOFT, INC. |
| Manufacturer Address | SUNNYVALE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-01-07 |
| 2 | 0 | 1. Other | 2011-01-07 |
| 3 | 0 | 1. Other | 2011-01-07 |
| 4 | 0 | 1. Other | 2011-01-07 |