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 2018-01-09 for GORE? VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[96727425]
(b)(4). The article stated the mean age was (b)(6), therefore (b)(6) was used for age. The article stated that 28 of 38 were male, therefore male used as patient gender. Date of event used is the date article accepted for publication, (b)(6) 2017. Desantis, adriano, nardelli, silvia, bassanelli, chiara, lupo, marinella, iegri, claudia, diciesco, carmela anna, forlina, mariana, farcomeni, alessio, and riggio, oliviero. "the modification of splenic stiffness on acoustic radiation force impulse parallels the variation of portal pressure induced by transjugular intrahepatic portosystemic shunt" accepted for publication in journal of gastroenterology hepatology: 2017 jul 28.
Patient Sequence No: 1, Text Type: N, H10
[96727426]
This information was received through abstract "the modification of splenic stiffness on acoustic radiation force impulse parallels the variation of portal pressure induced by transjugular intrahepatic portosystemic shunt" accepted for publication in journal of gastroenterology hepatology: 2017 jul 28. Doi: 10. 1111/jgh. 13907. The articles objective is to establish if the modification of portal pressure induced by a transjugular intrahepatic portosystemic shunt (tips) parallels the modification of spleen or liver stiffness. This prospective study took place between september 2013 and december 2015 and included 38 patients. The article reports one patient developed a persistent hepatic encephalopathy refractory to medical treatment one month after tips placement and was submitted to the reduction of the stent diameter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00008 |
| MDR Report Key | 7174860 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2018-01-09 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-07-28 |
| Date Added to Maude | 2018-01-09 |
| 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 | 2018-01-09 |
| 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. Required No Informationntervention | 2018-01-09 |