MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-17 for GORE VIATORR? TIPS ENDOPROSTHESIS PTB106275 manufactured by W.l. Gore & Associates.
[75526268]
Results code 1: 213 - a review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[75526269]
It was reported the physician selected a gore viatorr tips endoprosthesis for a transjugular intrahepatic portosystemic shunt (tips) procedure. Half way through deployment, the deployment line became stuck and stent deployment could not be completed. The device could not be pulled back into the delivery sheath and was removed from the patient partially deployed. A 14fr vascular catheter was then used to deliver a second 10mm x 6cm gore viatorr tips endoprosthesis and the case was concluded with no adverse events. The patient was doing well following the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2017-00124 |
| MDR Report Key | 6572301 |
| Date Received | 2017-05-17 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-04-21 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2017-05-17 |
| 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 | 2017-05-17 |
| Returned To Mfg | 2017-06-07 |
| Catalog Number | PTB106275 |
| Lot Number | 14821029 |
| Device Expiration Date | 2019-03-01 |
| 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 | 2017-05-17 |