MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-05-11 for GORE? VIATORR? TIPS ENDOPROSTHESIS PTB8108275 manufactured by W.l. Gore & Associates.
[107985860]
A review of the manufacturing records for the device verified that the lot met all pre-release specifications. The device remains implanted so no engineering investigation could be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[107985862]
It was reported that the physician was implanting a gore? Viatorr? Tips endoprosthesis with controlled expansion for a transjugular intrahepatic portosystemic shunt (tips) procedure. The patient presented with non occlusive portal vein thrombosis prior to tips implantation. The device was deployed to 8mm. According to the physician, the device appeared to completely cover the hepatic vein to the inferior vena cava on ct. The device was deployed and implanted without incident. The physician brought the patient in for a one-week follow up. The physician did not see any flow through the device under ultrasound and thought it may just be due to the wet-out of the ptfe device. The patient was brought back in due to worsened ascites and to re-do the ultrasound one week later (two weeks post implant) and the physician could still not see any flow through the device under ultrasound. Thrombosis of the device was suspected. The physician performed a venogram to determine the patency of the device. The venogram showed that the stent and portal vein had thrombosed and also showed thrombus in the smv. The physician is planning for the patient to get lysed overnight. After the patient was lysed, the patient came back for thrombectomy (angio jet, boston scientific). The physician dilated the viatorr cx stent and relined half of the viatorr cx with a covered stent and extended into the ivc. The physician lined the portal vein with a bare metal stent. The physician reports that the patient did very well. The patient was put on anticoagulants for 6 months. The physician stated that he can't say for sure that the thrombus was due to the device because there was preexisting portal vein thrombosis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00149 |
| MDR Report Key | 7506371 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-05-11 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-04-03 |
| Device Manufacturer Date | 2018-02-03 |
| Date Added to Maude | 2018-05-11 |
| 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 | ASHLEY MAROSTICA |
| 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 | 2018-05-11 |
| Catalog Number | PTB8108275 |
| Lot Number | 17738999 |
| 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 | 2018-05-11 |