MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-03 for GORE VIABAHN? ENDOPROSTHESIS - 3 VBJR051002A manufactured by W.l. Gore & Associates.
[188095894]
Additional manufacturer narrative: review of the manufacturing records indicated the device met pre-release specifications. The device was not returned. Consequently, a direct product analysis was not possible. All information has been placed on file for use in tracking and trending.
Patient Sequence No: 1, Text Type: N, H10
[188095895]
The following information was provided to gore: the patient presented with cto in the right sfa/proximal popliteal. The physician gained access through the left groin and performed up and over approach with 6 fr, 45 cm long sheath. Additionally, the physician gained pedal access and established a through and through wire. He then pre-dilated the lesion with a 5mm balloon, stating the pre-dilation looked good. The doctor alleged he experienced difficulty deploying the gore? Viabahn? Endoprosthesis and used the 2nd access point (pedal) to balloon assist the expansion of the device to remove of the catheter. The doctor also reported that during the balloon inflate/pull process, the gore? Viabahn? Endoprosthesis moved into the iliac artery partially covering the hypogastric artery and the profunda artery. At the completion of the procedure, the physician confirmed flow into the internal iliac and the profunda. The patient is reported to be fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00067 |
| MDR Report Key | 9661139 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-13 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2020-02-03 |
| 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 | CRAIG BEARCHELL |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | AZ |
| 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 | 2020-02-03 |
| Model Number | VBJR051002A |
| Catalog Number | VBJR051002A |
| Lot Number | 18525830 |
| 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. Other | 2020-02-03 |