MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-03 for GORE ACUSEAL VASCULAR GRAFT manufactured by W.l. Gore & Associates.
[187878396]
The other reportable complication: graft infection gore? Propaten? Vascular graft is being reported under mfr. # 2017233-2020-00008.
Patient Sequence No: 1, Text Type: N, H10
[187878397]
The following publication was reviewed: comparison on forearm loop vascular accesses using gore? Propaten? Vascular graft and gore? Acuseal vascular graft. Introduction: gore? Propaten? Vascular graft (hereinafter, propaten) had been used for cases in which internal shunt by autogenous vein is difficult to create before 2015, however, from january 2015, gore? Acuseal vascular graft (hereinafter, acuseal), which has excellent hemostatic features due to its thick wall of 1. 4 mm and allows early perforation, has been the initial choice in principle. At this time, the treatment results of propaten and acuseal were compared. Method and results: we examined retrospectively 46 cases in which vascular access of forearm loop was created from january 2015 to december 2018. Propaten group (hereinafter, group p) was 22 cases (47. 8%), and acuseal group (hereinafter, group a) was 24 cases (52. 2%). The average age was 70. 5? 12. 9 years old for group p, and 66. 3? 11. 1 years old (p=0. 27) for group a. The average operation period was 146? 41. 3 minutes for group p, and 159? 42. 4 minutes (p=0. 20) for group a. The amount of bleeding was 33? 29 ml for group p, and 21? 33 ml (p=0. 01) for group a. The bleeding amount of group a was significantly less. Regarding postoperative complication, steal syndrome was recognized in 1 case, and graft infection was recognized in 1 case for group p. Stenosis/occlusion was recognized in 2 cases, and graft infection was recognized in 1 case for group a (p=0. 71). The average observation period was 7. 1 months? 6. 7 months for group p, and 11. 8? 7. 8 months (p=0. 02) for group a. The primary patency at six months was 62. 3 % for group p, 55. 6 % (p=0. 18) for group a, the assisted-primary patency at six months was 89. 5 % for group p, and 59. 9% (p=0. 08) for group a. The secondary patency was 95. 5% for group p, and 73. 3 % (p=0. 10) for group a. The secondary patency of group a tends to be lower than group p. Consideration: acuseal has excellent hemostatic features due to its thick wall, thus, early perforation was possible and the amount of bleeding during operation was few. However, there were more postoperative early occlusion, and the patency tends to be lower. It is essential to use a suitable graft by understanding the characteristics of each graft.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017233-2020-00007 |
| MDR Report Key | 9547441 |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-04 |
| Date of Event | 2019-10-01 |
| Date Added to Maude | 2020-01-03 |
| 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 | HEIDI INSKEEP |
| 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 | 2020-01-03 |
| 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. Other; 3. Required No Informationntervention | 2020-01-03 |