MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-11-14 for GORE VIATORR? TIPS ENDOPROSTHESIS PTB108275 manufactured by W.l. Gore & Associates.
[59787614]
The device was discarded by the facility and a lot number was not provided; therefore, further investigation was unable to be performed. Additional information received from the facility noted the bare metal portion of the stent was not released in the correct location (portal vein).
Patient Sequence No: 1, Text Type: N, H10
[59787615]
A facility generated voluntary medwatch report was forwarded to gore from the fda. The report notes a gore viatorr tips endoprosthesis is associated with a serious injury. The report states "when passing stent through an ij sheath for a tips procedure, one of the struts stuck on the end of sheath (just past the hub). Radiologist unable to move the stent forward or retract. The stent was removed in the operating room in an open procedure. " gore obtained the following additional information from the facility: the bare metal portion of the stent was released prior to reaching the portal vein; subsequently, it deployed in the parenchymal tract. The physician pulled the device back into the internal jugular, but was unable to retract the bare metal portion of the stent into the sheath. The patient was sent to the operating room to have the device removed from the internal jugular. The following day, the patient had a successful tips procedure.
Patient Sequence No: 1, Text Type: D, B5
[61652629]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007284313-2016-00230 |
| MDR Report Key | 6099902 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-11-14 |
| Date of Report | 2016-12-06 |
| Date of Event | 2016-09-22 |
| Date Added to Maude | 2016-11-14 |
| 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 | 2016-11-14 |
| Catalog Number | PTB108275 |
| Device Expiration Date | 2018-12-17 |
| 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 | 2016-11-14 |