MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[122375977]
Device lot number(s) were not provided; therefore, an investigation is unable to be performed and a cause of the reported events cannot be determined. The gore? Viatorr? Tips endoprosthesis instructions for use (ifu) note the risks and potential adverse effects of creating a tips in patients with pre-existing conditions such as hepatic encephalopathy must be considered relative to the potential benefits of this procedure. Further, the ifu states, "patients should be monitored closely following the procedure for worsening hepatic encephalopathy. Those patients who develop hepatic encephalopathy that is not responsive to medical therapy may require reduction or occlusion of the tips tract to control the symptoms. " citation: frakes cm, singh t, sarvepalli s, mccullough a, kapoor b. 30-day readmission rate after transjugular intrahepatic portosystemic shunt. Presented at the 69th annual meeting of the american association for the study of liver diseases (aasld): the liver meeting "november" 9-13, 2018; san francisco, ca. Gastroenterology 2018; 154 (6) supplement 1: s-1219. Tu1448.
Patient Sequence No: 1, Text Type: N, H10
[122375978]
This information was received through abstract? 30-day readmission rate after transjugular intrahepatic portosystemic shunt" published in gastroenterology in may 2018. The abstract reports the aim of the study was to identify the readmission rate after tips, most common etiology for readmission, and search for potential protective factors association with decreasing readmission rates. Study subjects included 163 patients who underwent primary tips placement with viatorr self-expandable ptfe covered stent grafts from 2011-2016. The abstract reported a 30-day readmission rate of 28. 2%. The most common cause for readmission was confusion related to hepatic encephalopathy, a complication related to tips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00275 |
| MDR Report Key | 7927406 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-05-01 |
| Date Added to Maude | 2018-10-02 |
| 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 | 2018-10-02 |
| 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 | 2018-10-02 |