MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-11 for GORE? VIABAHN? VBX BALLOON EXPANDABLE ENDOPROSTHESIS BXAL085902A manufactured by W.l. Gore & Associates.
[187931811]
Additional manufacturer narrative: a review of the manufacturing records indicated the device met pre-release specifications. The device was not returned for an engineering evaluation. Consequently, a direct product analysis was not possible. Additional information about this event could not be obtained. As a result, no further investigation is possible.
Patient Sequence No: 1, Text Type: N, H10
[187931812]
The following was reported to gore: on (b)(6) 2020 the patient presented with complete occlusion of the right common iliac. An 8lmm x 59mm gore? Viabahn? Vbx balloon expandable endoprosthesis was successfully deployed and blood flow was restored. Approximately 2 hours after the completion of the surgery, the patient complained of leg pain. The patient was brought into the or and an angiogram was performed. It was then noticed that the previously implanted device had occluded. The physician reopened the cut down and used a fogarty balloon to remove the clot and administered heparin and eliquis to reduce clotting. It was reported the patient tolerated the procedure and is doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00088 |
| MDR Report Key | 9694896 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-11 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-14 |
| Device Manufacturer Date | 2019-03-26 |
| Date Added to Maude | 2020-02-11 |
| 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 | NICK LA FAVE |
| 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? VBX BALLOON EXPANDABLE ENDOPROSTHESIS |
| Product Code | PRL |
| Date Received | 2020-02-11 |
| Model Number | BXAL085902A |
| Catalog Number | BXAL085902A |
| Lot Number | 20503991 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Required No Informationntervention | 2020-02-11 |