MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2017-12-06 for GORE? VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[93841446]
(b)(4) - a review of the manufacturing records for the device could not be conducted because the lot # remains unknown. Campos, sara, gomes, dario, and sofia, carlos. "transjugular intrahepatic portosystemic shunt in refractory hydrothorax? A contribution to an unexplored indication" published in european journal of gastroenterology & hepatology, june 2016.
Patient Sequence No: 1, Text Type: N, H10
[93841447]
This information was received through literature article "transjugular intrahepatic portosystemic shunt in refractory hydrothorax? A contribution to an unexplored indication" published in european journal of gastroenterology & hepatology, (b)(6) 2016. This article is a retrospective study including patients with refractory hydrothorax undergoing tips between 2000 and 2014. The aim of this study was to evaluate the efficacy and safety of tips in patients with refractory hydrothorax. The article reports one patient death within 30 days of tips creation due to liver ischemia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2017-00294 |
| MDR Report Key | 7086522 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2017-12-06 |
| Date of Report | 2017-11-10 |
| Date of Event | 2016-06-01 |
| Date Added to Maude | 2017-12-06 |
| 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 | KATHY TITUS |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL PHOENIX 1 B/P |
| Manufacturer Street | 32360 N. NORTH VALLEY PARKWAY |
| Manufacturer City | PHOENIX AZ 85085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE? VIATORR? TIPS ENDOPROSTHESIS |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2017-12-06 |
| 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. Death | 2017-12-06 |