MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-13 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[116996732]
The gore? Viatorr? Tips endoprosthesis instructions for use precaution section notes the graft-lined portion of the gore? Viatorr? Tips endoprosthesis should completely cover the intrahepatic tract, preferably to the ostium of the hepatic vein at the inferior vena cava. Additionally, thrombosis is listed as a possible adverse event in the gore? Viatorr? Tips endoprosthesis instructions for use. Regnaulta d, d? Alterochea l, nicolasa c, dujardinb f, ayoubc j, perarnau jm. Ten-year experience of transjugular intrahepatic portosystemic shunt for noncirrhotic portal hypertension. European journal of gastroenterology & hepatology 2018; 30:557? 562.
Patient Sequence No: 1, Text Type: N, H10
[116996733]
This information was received through literature article "ten-year experience of transjugular intrahepatic portosystemic shunt for noncirrhotic portal hypertension" published in the european journal of gastroenterology and hepatology, may 2018. The study is a monocentric retrospective study concerning patients treated by tips between 2004 and 2015 for complications of noncirrhotic portal hypertension. The article reports an early complication (< 30 days) with a gore? Viatorr? Tips endoprosthesis. An asymptomatic early thrombosis was detected via ultrasound on day five following implant. It was further reported that too short a stent was initially placed requiring a new and longer 1 cm stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00225 |
| MDR Report Key | 7779221 |
| Date Received | 2018-08-13 |
| Date of Report | 2018-07-18 |
| Date of Event | 2018-05-15 |
| Date Added to Maude | 2018-08-13 |
| 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 | MARCI STEWART |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | FLAGSTAFF AZ |
| 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 | 2018-08-13 |
| 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; 2. Required No Informationntervention | 2018-08-13 |