MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-17 for GORE? VIATORR? TIPS ENDOPROSTHESIS PTB108275 manufactured by W.l. Gore & Associates.
[97960081]
A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met. Udi: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[97960082]
It was reported the physician selected a gore? Viatorr? Tips endoprosthesis for a transjugular intrahepatic portosystemic shunt procedure. The device was advanced and placed in the desired location. Two thirds of the device was deployed when the deployment line became stuck and full deployment could not be completed. The physician made multiple attempts to complete deployment using endovascular techniques, but was unsuccessful. A direct portal stick was performed and a snare was used to capture the end of the guidewire in attempt to better maneuver the stent/deployment line. Deployment was again attempted; however, the deployment line broke along with approximately 10-12cm of the delivery catheter. A 16fr sheath was introduced and the delivery catheter fragment was snared from the patient. A 5mm balloon was then advanced and deployed inside the stent in an attempt to complete deployment, but the balloon broke and was removed. A non-compliant balloon was then advanced and deployed; the stent opened completely and remains implanted. There were no reported adverse effects for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00020 |
| MDR Report Key | 7199152 |
| Date Received | 2018-01-17 |
| Date of Report | 2018-01-26 |
| Date of Event | 2017-12-22 |
| Device Manufacturer Date | 2017-10-29 |
| Date Added to Maude | 2018-01-17 |
| 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 | 0 |
| Brand Name | GORE? VIATORR? TIPS ENDOPROSTHESIS |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2018-01-17 |
| Returned To Mfg | 2018-01-15 |
| Catalog Number | PTB108275 |
| Lot Number | 17385379 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-01-17 |