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.
[122446027]
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: rowley mw, choi m, chen s, hirsch k, seetharam ab. Refractory hepatic encephalopathy after elective transjugular intrahepatic portosystemic shunt: risk factors and outcomes with revision. Cardiovascular & interventional radiology, june 2018.
Patient Sequence No: 1, Text Type: N, H10
[122446028]
This information was received through literature article? Refractory hepatic encephalopathy after elective transjugular intrahepatic portosystemic shunt: risk factors and outcomes with revision" published in the journal of cardiovascular and interventional radiology, june 2018. This article describes a retrospective cohort study of 174 consecutive patients undergoing elective tips placement from 2010-2015 utilizing gore? Viatorr? Tips endoprostheses. All stents had a nominal diameter of 10mm. This article evaluated the incidence, predictors, and outcomes of post-tips refractory hepatic encephalopathy (rfe) necessitating tips revision. Ten of the 174 subjects developed post-tips rhe requiring revision. Of these ten patients, three underwent revision within 30 days of the primary tips procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00277 |
| MDR Report Key | 7928083 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-06-05 |
| 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 |