MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for GORE? VIATORR? TIPS ENDOPROSTHESIS PTB087275W manufactured by W.l. Gore & Associates.
[108905382]
(b)(4). The review of the manufacturing records verified that the lot met all pre-release specifications. The engineering evaluation stated that the device was returned with the endoprosthesis partially constrained between the introducer sheath and the catheter with the access sleeve pulled back from the tip of the catheter. During the engineering evaluation and after removal of the sheath, the device was successfully deployed. Further inspections revealed no other device abnormalities. Based on the returned state, it is possible that the deployment line became stuck because the endoprosthesis remained partially constrained within the introducer sheath. However, once the introducer sheath was pulled completely off the endoprosthesis during the engineering evaluation, the device was deployed successfully.
Patient Sequence No: 1, Text Type: N, H10
[108905383]
It was reported to gore that the physician was implanting a gore? Viatorr? Tips endoprosthesis for a treatment of the haematemesis of upper digestive tract and spitting blood for 5 days. The device was advanced through a cook rups100 sheath over an ev. 3 guide wire. It was stated that there was some resistance during inserting through the sheath, but extra force still can continue insertion. After the device was advanced to the portal vein, the physician withdrew the sheath to deploy the lined region firstly. To ensure the golden circumferential radiopaque marker being at the junction of portal vein and liver parenchyma, the physician wanted to withdraw the catheter and adjust but a resistance was felt. The physician tried moving the catheter back and forth to overcome the resistance, however the catheter was reportedly stuck in the sheath so could not move. During attempt of catheter adjustment, a part of line region was observed protruding out of the sheath and expanded under angiography, even the physician never pulled the deployment knob. The physician decided to retract the device, there was also difficulty but finally able to retract the device out of the patient together with the sheath after several attempts. The physician used a new viatorr? Device of the same size to continue the procedure. The procedure was completed successfully and the patient recovered well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00157 |
| MDR Report Key | 7528793 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-30 |
| Date of Event | 2018-03-12 |
| Device Manufacturer Date | 2017-07-14 |
| Date Added to Maude | 2018-05-21 |
| 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 | HELEN HUANG |
| 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 | 2018-05-21 |
| Returned To Mfg | 2018-04-13 |
| Catalog Number | PTB087275W |
| Lot Number | 16501850 |
| 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 | 2018-05-21 |