MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-24 for GORE ACUSEAL VASCULAR GRAFT ECH060040J manufactured by W.l. Gore & Associates.
[188376725]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188376726]
On an unknown date, around 2018 - 2019, the patient was implanted with a gore? Acuseal vascular graft as an av shunt for hemodialysis on the left forearm. On an unknown date, in late 2019, follow-up echo examination showed graft delamination. Graft occlusion was also confirmed at the same site. On an unknown date, pta ballooning was performed to treat the delamination and occlusion. On an unknown date, the graft occlusion and the graft delamination were confirmed again at the same site. On an unknown date, pta ballooning was performed to treat the delamination and occlusion. The graft remains implanted and the patient is being monitored. The physician reportedly commented it was not determined if the graft delamination occurred at the puncture site or not. The cause of the occlusion is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00126 |
| MDR Report Key | 9745238 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-26 |
| Date of Event | 2019-12-01 |
| Date Added to Maude | 2020-02-24 |
| 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 WEST B/P |
| Manufacturer Street | 1505 N. FOURTH STREET |
| Manufacturer City | FLAGSTAFF AZ 86004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 86004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE ACUSEAL VASCULAR GRAFT |
| Generic Name | PROSTHESIS, VASCULAR GRAFT |
| Product Code | DSY |
| Date Received | 2020-02-24 |
| Catalog Number | ECH060040J |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-02-24 |