MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number ECH060040A

Device Problem Human-Device Interface Problem (2949)

Patient Problem Erosion (1750)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

Article: evaluation of heparin-bonded eptfe grafts for forearm loop vascular access: comparison between gore® propaten vascular graft and acuseal vascular graft.Authors: takeshi baba , takao ohki, koji maeda, eisaku ito, masamichi momose, yoshihiko chono, makiko omori and kota shukuzawa.The journal of vascular access 2021 mar 8; doi: 10.1177/1129729821998526.Mfr report # 2017233-2021-01996 was submitted based on this article.Average age is 65; majority of patient are male.Date published was used as date of event.(b)(4).Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following publication was reviewed: evaluation of heparin-bonded eptfe grafts for forearm loop vascular access: comparison between gore® propaten vascular graft and acuseal vascular graft source: the journal of vascular access 2021 mar 8; doi: 10.1177/1129729821998526.This retrospective study evaluates the clinical outcomes of gore® acuseal vascular grafts and gore® propaten® vascular grafts for forearm loop vascular access.Between january 2015 and december 2019, data was collected on 60 patients.Enrolled were 36 patients in the propaten group (group p) and 24 in the acuseal group (group a).All procedures were successful without any 30-day mortality.The median times to first cannulation were 16.5 days for group p and 3 days for group a.Mean follow-up periods were 13.4 ± 14.5 and 17.3 ± 9.3 months, respectively.Primary patency rates were 81% and 64%, respectively, at 6 months, and 60% and 40%, respectively, at 12 months.Assisted primary patency rates were 96% and 83% at 6 months, 91% and 73% at 12 months, and 81% and 35% at 24 months.Secondary patency rates were 96% and 81% at 12 months, and 87% and 62% at 24 months.The article did not report any early complications.However, there was one acuseal graft exposure with wound dehiscence reported due to weak skin or poor subcutaneous tissue.As stated in the article, an eptfe graft with an inner diameter of 6mm has an outer diameter of 7.5mm, compared to a 6mm acuseal vascular graft that has outer diameter of 8.8 mm, making the graft thicker by 1.3 mm.Therefore, the possibility of graft exposure associated with wound dehiscence in patients with weak skin or poor subcutaneous tissue must be considered.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11822155
• MDR Text Key: 265164087
• Report Number: 2017233-2021-02003
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECH060040A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65