MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-05 for GORE VIABAHN? ENDOPROSTHESIS - 3 VBH061002W manufactured by W.l. Gore & Associates.
[180727703]
A review of the manufacturing records indicated the device met pre-release specifications. The imaging could not be performed as the images were not available. The device was waiting to be returned.
Patient Sequence No: 1, Text Type: N, H10
[180727704]
The following was reported to gore: on (b)(6) 2020 a patient was implanted with a 6mm x 10cm gore? Viabahn? Endoprosthesis with heparin bioactive surface to treat femoral artery stenosis. A 6fr medtronic sheath and terumo ver catheter were inserted for angiography. It showed common femoral artery stenosis. Boston v18 guidewire and biotronik pta were inserted to dilate the vessel, however the blood flow wasn't improved. Then viabahn? Device was advanced to target lesion and deployed. However, the deployment line got stuck when the viabahn? Device expanded half. The viabahn? Device couldn't deploy after many attempts. After that the physician performed a surgical intervention to remove the viabahn? Device. It was reported that a surgical bypass was performed using a gore vascular graft to complete the procedure successfully. The patient tolerated the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00076 |
| MDR Report Key | 9674179 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-05 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-08 |
| Device Manufacturer Date | 2017-11-22 |
| Date Added to Maude | 2020-02-05 |
| 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 | PIXIE XI |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL ECHO RIDGE B/P |
| Manufacturer Street | 3250 W. KILTIE LANE |
| Manufacturer City | FLAGSTAFF AZ 86005 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE VIABAHN? ENDOPROSTHESIS - 3 |
| Generic Name | NIP |
| Product Code | PFV |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-02-12 |
| Catalog Number | VBH061002W |
| Lot Number | 17796599 |
| 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. Required No Informationntervention | 2020-02-05 |