MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-08 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[123048934]
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. Citation: amin, a. , chang, y. S. , sullivan, t. , salsamendi j. Retrieval of a retained transjugular intrahepatic portosystemic shunt stent graft deployment line. J vasc interv radiol 2018; 29:1330-1331.
Patient Sequence No: 1, Text Type: N, H10
[123048935]
This information was received through literature article? Retrieval of a retained transjugular intrahepatic portosystemic shunt stent graft deployment line" published in the journal of vascular and interventional radiology, (b)(6) 2018. This article reports a patient with end-stage liver disease incidentally had a long, linear, echogenic, and mobile foreign body in the right atrium that extended through the tricuspid valve into the right ventricle identified during echocardiography performed before transplant. She had undergone tips creation with a gore? Viatorr? Tips endoprosthesis one month prior with no reported complications. Under intravascular ultrasound, a 6fr catheter and goose neck snare catheter was used to remove the foreign body which was identified as the deployment line of the tips delivery system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00283 |
| MDR Report Key | 7944665 |
| Date Received | 2018-10-08 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-09-01 |
| Date Added to Maude | 2018-10-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-10-08 |
| 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. Required No Informationntervention | 2018-10-08 |