MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/01/2019

Event Type  Injury  

Manufacturer Narrative

The other reportable complication: graft infection gore® acuseal vascular graftis being reported under mfr.Report # 2017233-2020-00007.

Event Description

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.

Manufacturer Narrative

Literature citation: momose, t.(october 2019) comparison on forearm loop vascular accesses using gore® propaten® vascular graft and gore® acuseal vascular graft, angiology volume 59 suppl.Page s240.

Event Description

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 (b)(6) 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.This report addresses the graft infection of the gore® propaten® vascular graft.

Manufacturer Narrative

B.5.Updated.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; - manufacturer/compounder: w.L.Gore & associates, inc.- lot #unk.- cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9547592
• MDR Text Key: 186573085
• Report Number: 2017233-2020-00008
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/24/2020; 06/03/2020; 06/03/2020; 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 70 YR