MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-22 for GORE ACUSEAL VASCULAR GRAFT ECH460045A manufactured by W.l. Gore & Associates.
[187880596]
Review of the manufacturing records verified that the lot met release requirements. 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
[187880597]
The following was reported to gore: the patient received a fistula for av access at the university hospital of (b)(6) and is sent home to (b)(6) for dialysis at fresenius kidney care. After approximately 2 weeks of dialysis with the fistula, the patient returns to university hospital of (b)(6), as the fistula has become non-functional (unable to be used for dialysis). The fistula is abandoned and the surgeon who created the fistula, implants a gore? Acuseal vascular graft on (b)(6) 2020 in the upper arm. The patient returns to hazard, kentucky for dialysis. Patient presented at fresenius kidney care ((b)(6)) for dialysis (b)(6) 2020 (2 days post implant). Two 17 gauge dialysis needles are used to access inflow and outflow of the acuseal graft and the dialysis machine is adjusted to 100ml per minute for the initial time period on dialysis. During the dialysis session the patient complained about arm pain and swelling/hematoma was observed. The patient was sent to (b)(6) medical center er with the two dialysis needles still in the arm. Fasciotomy is performed to control bleeding and to treat compartment syndrome. The er surgeon reported there were no visible problems associated with the gore? Acuseal vascular graft and both venous and arterial anastomoses appeared intact. The two dialysis needle cannulation holes were observed on the anterior aspect of the graft. Er surgeon placed a stay-suture on one of the cannulation needle holes of the acuseal graft. On (b)(6) 2020 the later patient returns to university hospital of (b)(6) where a fistula gram is performed by the implanting surgeon. During the procedure the surgeon observed that the gore? Acuseal vascular graft was functioning as intended, no outflow stenosis was observed, and that a suture had been placed on one of the needle holes of the graft. The patient is currently recovering and dialyzing through a catheter until the surgeon decides when to initiate cannulation through the acuseal graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00048 |
| MDR Report Key | 9618623 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-07 |
| Date of Event | 2020-01-04 |
| Device Manufacturer Date | 2019-10-11 |
| Date Added to Maude | 2020-01-22 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 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 | 2020-01-22 |
| Model Number | ECH460045A |
| Catalog Number | ECH460045A |
| Lot Number | 6535184PP002 |
| 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. Required No Informationntervention | 2020-01-22 |