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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Occlusion (1984)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: the reported graft occlusion occurred within 30 days of initial implant procedure, (b)(6) 2016 will be determined as the date of event.Date of device implant: in this literature article, the gore® acuseal vascular grafts were implanted during 2016, so that it (b)(6) 2016 will be determined as the date of initial implant.(b)(4).A review of the manufacturing records for the device could not be conducted the item- and lot numbers of the device were not available.According to the gore® acuseal vascular graft instructions for use (ifu), complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to thrombosis.(b)(4).

Event Description

The following information was obtained through literature review of the article below: h, ihara., et al (october, 2017)."treatment results using gore® acuseal vascular graft." access.83.74-75.From january 2016 to november 2016, 27 patients (16 males and 11 females) underwent 29 arterio-venous shunt procedures using gore® acuseal vascular grafts.Those shunts were prepared in the patient¿s upper arms or forearms.New arterio-venous shunt preparation procedure was performed in 4 cases while the other 25 cases were arterio-venous access revision procedures.Of these 25 revision cases, indication for the revision procedure was reported as follows: 17 cases for vessel occlusion, 3 for infection of the previously implanted vascular graft, 3 for venous hypertension, 1 for aneurysm at an anastomosis site, and 1 for excessive blood flow.The following events were reported as post-procedure complications related to the gore® acuseal vascular graft: 3 cases of graft occlusion which occurred within 30 days post initial implant procedure and 1 case of graft infection at a non-dialysis access site.Regarding the graft occlusion, it was reported that one case was revealed in the next day of the initial procedure, another was revealed two weeks post initial procedure, and the other was one month post initial procedure.The reintervention procedures performed for graft occlusion include new bypass preparation, extension of the existing graft and balloon angioplasty.Regarding the graft infection, the infected portion of the graft was replaced with another gore® acuseal vascular graft.Further information was not available.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7240299
• MDR Text Key: 98969305
• Report Number: 2017233-2018-00071
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention