MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-27 for GORE? VIABAHN? VBX BALLOON EXPANDABLE ENDOPROSTHESIS BXA067902E manufactured by W.l. Gore & Associates.
| Report Number | 2017233-2020-00216 |
| MDR Report Key | 9889849 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-18 |
| Date of Event | 2019-11-29 |
| Device Manufacturer Date | 2018-10-09 |
| Date Added to Maude | 2020-03-27 |
| 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 | SIBYLLE STAERK |
| 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 | 2020-03-27 |
| Catalog Number | BXA067902E |
| Lot Number | 20382433 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization | 2020-03-27 |