MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-02 for GORE? VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[98964433]
Article citation: thornburg, b. , desai, k. , hickey, r. , hohlastos, e. , kulik, l. , ganger, d. ,. . . Salem, r. (2017). Pretransplantation portal vein recanalization and transjugular intrahepatic portosystemic shunt creation for chronic portal vein thrombosis: final analysis of a 61-patient cohort. Journal of vascular and interventional radiology, 28(12). Doi:10. 1016/j. Jvir. 2017. 08. 005. A review of the manufacturing records for the devices could not be conducted because the lot #s remain unknown. The devices remain implanted so no engineering investigation could be performed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[98964434]
This information was received through the literature article, "pretransplantation portal vein recanalization and transjugular intrahepatic portosystemic shunt creation for chronic portal vein thrombosis: final analysis of a 61-patient cohort. " it was reported 5 patients experienced recurrent pv/tips thrombosis during follow up. Four recurrent pv/tips thrombosis were detected at or before the 1-month follow-up venogram. In 4 patients tips revision and recanalization was attempted and was successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00039 |
| MDR Report Key | 7239125 |
| Date Received | 2018-02-02 |
| Date of Report | 2018-03-23 |
| Date of Event | 2017-08-08 |
| Date Added to Maude | 2018-02-02 |
| 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 | 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 | 0 |
| Brand Name | GORE? VIATORR? TIPS ENDOPROSTHESIS |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2018-02-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-02-02 |