MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-04 for GORE? VIABAHN? VBX BALLOON EXPANDABLE ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[188218601]
Review of the manufacturing records could not be performed as no lot number information was provided. The device was not returned. Consequently, direct product analysis was not possible. Additional information about this event could not be obtained. As a result, no conclusion can be drawn. All information has been placed on file for use in tracking and trending. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188218602]
Conference presentation 'short term outcome of gore vbx stent grafts compared to atrium icast stent grafts for fevar' (c. Deslarzes-dubuis, m. D. ; kenneth tran, m. D. ; benjamin colvard, m. D. ; graeme mcfarland, m. D. ; michael sgroi, m. D. ; jason lee, m. D. ; 2019 charing cross; stanford medicine - vascular & endovascular surgery) was reviewed. The presentation compares the gore? Viabahn? Vbx balloon expandable endoprosthesis (vbx) to the icast performance for renal stenting in fenestrated endovascular repair (fevar). The presentation identifies complications for the vbx cohort that included one stent stenosis in the left renal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00143 |
| MDR Report Key | 9787730 |
| Date Received | 2020-03-04 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-09-21 |
| Date Added to Maude | 2020-03-04 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | CRAIG BEARCHELL |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL ECHO RIDGE B/P |
| Manufacturer Street | 3250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE? VIABAHN? VBX BALLOON EXPANDABLE ENDOPROSTHESIS |
| Generic Name | STENT, ILIAC |
| Product Code | NIO |
| Date Received | 2020-03-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-04 |