MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-10 for GORE VIATORR TIPS ENDOPROSTHESIS PTB8106275 manufactured by W. L. Gore & Associates, Inc..
[82397140]
Patient Sequence No: 1, Text Type: N, H10
[82397141]
A portion of the deployment mechanism (string) was discovered at surgical incision during completion of transjugular intrahepatic portosystemic shunt (tips) procedure. The portion had broken off the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6784210 |
| MDR Report Key | 6784210 |
| Date Received | 2017-08-10 |
| Date of Report | 2017-07-14 |
| Date of Event | 2017-07-13 |
| Report Date | 2017-07-14 |
| Date Reported to FDA | 2017-07-14 |
| Date Reported to Mfgr | 2017-07-14 |
| Date Added to Maude | 2017-08-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| 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 | 2017-08-10 |
| Model Number | PTB8106275 |
| Catalog Number | PTB8106275 |
| ID Number | 8-10MM X 6 CM -2CM. 10FR |
| Device Expiration Date | 2019-11-22 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W. L. GORE & ASSOCIATES, INC. |
| Manufacturer Address | 32360 N. NORTH VALLEY PARKWAY PHOENIX AZ 85085 US 85085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-10 |