MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-28 for GORE VIABAHN? ENDOPROSTHESIS - 3 VBH100502A manufactured by W.l. Gore & Associates.
[188725293]
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Patient Sequence No: 1, Text Type: N, H10
[188725294]
On (b)(6) 2020, the patient underwent treatment for a popliteal artery occlusion using gore? Viabahn? Endoprostheses. It was reported a gore? Viabahn? Endoprosthesis (vbh100502a/20466865) was advanced into its intended location. Reportedly the deployment line was pulled, however, the device failed to completely expand leaving a portion of the device constrained. The physician ballooned the gore? Viabahn? Endoprosthesis and the device was fully expanded. However, as the deployment catheter was being removed from the patient, it was observed that the popliteal artery had ruptured. The procedure was completed with the physician performing a fem-pop bypass using a vascular graft. The patient tolerated the procedure. The physician stated it is unknown what caused the partial device expansion or the rupture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00133 |
| MDR Report Key | 9769531 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-28 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-31 |
| Device Manufacturer Date | 2019-03-12 |
| Date Added to Maude | 2020-02-28 |
| 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 | MARCOS AYALA |
| 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 | 2020-02-28 |
| Model Number | VBH100502A |
| Catalog Number | VBH100502A |
| Lot Number | 20466865 |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-28 |