MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-26 for GORE VIATORR TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION PT8108275 manufactured by W.l. Gore & Associates.
[125192310]
The images provided did not have a calibration scale and were two-dimensional; therefore the exact diameters of the gore? Viatorr? Tips endoprosthesis with controlled expansion device were not able to be determined. This image evaluation was unable to confirm that the gore? Viatorr? Tips endoprosthesis with controlled expansion device that had been dilated to 7 mm in the initial procedure self-expanded to 10 mm prior to the reduction procedure. However, the overall device shape at the proximal end and relative proportions is what gore would expect for a device that still has an 8 mm inner diameter in the constrained portion and 10 mm diameter on the ends in both the image from the initial procedure as well as the image from the reduction procedure. The instructions for use for gore? Viatorr? Tips endoprosthesis with controlled expansion 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.
Patient Sequence No: 1, Text Type: N, H10
[125192311]
It was reported to gore a gore? Viatorr? Tips endoprosthesis with controlled expansion was implanted on (b)(6) 2018 during a transjugular intrahepatic portosystemic shunt (tips) procedure to treat bleeding "oesphageal" varices. At discharge on (b)(6) 2018 it was reported there were no signs of hepatic encephalopathy. It was reported that following placement of the gore? Viatorr? Tips endoprosthesis with controlled expansion stent the patient has suffered with hepatic encephalopathy leading to a decision to perform a reduction procedure. At the original procedure in (b)(6) 2018, the gore? Viatorr? Tips endoprosthesis with controlled expansion stent was dilated to 7mm. At the reduction procedure on (b)(6) 2018 the stent appeared to have fully dilated to 10mm. The gore? Viatorr? Tips endoprosthesis with controlled expansion was reduced by insertion of a 10mm x 59mm v12 stent that was left with a waste of approximately 4mm and flared ends. The physician reports the patient has improved significantly and he has become alert and oriented. The patient has not yet bled from any new varices that may or may not be present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00304 |
| MDR Report Key | 8010877 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-26 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-10-03 |
| Device Manufacturer Date | 2017-11-10 |
| Date Added to Maude | 2018-10-26 |
| 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 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 WITH CONTROLLED EXPANSION |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2018-10-26 |
| Catalog Number | PT8108275 |
| Lot Number | 17432051 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-10-26 |