MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for GORE? VIATORR? TIPS ENDOPROSTHESIS PTB108275 manufactured by W.l. Gore & Associates.
[91741802]
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
[91741803]
It was reported the physician selected a gore? Viatorr? Tips endoprosthesis for a transjugular intrahepatic portosystemic shunt procedure. The physician was not able to advance the device through a 10fr cook introducer sheath; the deployment line unraveled and the stent deployed in the sheath. Both the viatorr? Device and introducer sheath were removed. A new introducer sheath was placed and a second viatorr? Device was advanced and deployed without issue. The physician then lined the viatorr? Device with s. M. A. R. T.? Control? Stents for support as the device was deployed in very tortuous anatomy. As the introducer sheath was removed and pressure was held on the access site for closure, the patient suffered cardiac arrest and passed away. It was further reported the patient suffered cardiac arrest in the intensive care unit prior to the tips procedure. Additionally, a sengstaken-blakemore tube was already in place to control variceal bleeding prior to the procedure. The patient was reported to be unstable throughout the tips procedure. The physician does not attribute the patient's death to the gore? Viatorr? Tips endoprostheses, as the patient's health was already extremely compromised.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2017-00268 |
| MDR Report Key | 7016541 |
| Date Received | 2017-11-09 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-10-19 |
| Device Manufacturer Date | 2017-07-18 |
| Date Added to Maude | 2017-11-09 |
| 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 | 2017-11-09 |
| Catalog Number | PTB108275 |
| Lot Number | 16513151 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Death | 2017-11-09 |