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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis (2100)

Event Date 12/16/2019

Event Type  Injury  

Manufacturer Narrative

For further evaluation the author was asked, if more details such as lot-no., implant- and explant dates, as well as patient details are available.The results will be included in the final report.Date of event was determined as date when literature article was published, here (b)(6) 2019.As patient age (b)(6) years was determined, and as gender male as mentioned in the article.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

Within the article a case of dissection in an acuseal-modified hero graft from nicholas a bradley published in the journal of vascular access on december 16, 2019, vol.21(6) 1045-1048 the following was indicated: background: the use of the hemodialysis reliable outflow (hero¿; merit medical systems inc.South jordan, utah, usa) graft system with the early-access acuseal graft avoids the need for a tunnelled dialysis catheter as a bridge for vascular access.Established complications of this system include thrombosis, graft infection, haematoma, and pseudoaneurysm formation.Case description: a (b)(6) year-old patient found to have a dissection flap at the venous cannulation point (acuseal component) of a right arm hero graft.The acuseal was replaced in theatre and subsequent duplex imaging confirmed satisfactory graft function.Conclusion: this case demonstrates a serious yet previously undescribed complication of cannulation of an acuseal graft.The trilaminar construction of the graft may increase the likelihood of disruption of the luminal layer during repeated needling and predispose it to dissection.Given the consequences of graft failure in such patients, urgent intervention is warranted when graft dissection is suspected.The hero¿ device had previously required three subsequent thrombectomies for thrombosis within acuseal¿ eptfe grafts.Our experience of acuseal¿ thromboses is that they relate to platelet plug formation at the needling site.

Manufacturer Narrative

H3: other; there was no device return; therefore, no physical evaluation of the device could be performed.Multiple attempts were made to obtain additional information from the author about this event.No additional information was provided; therefore, no further investigation could be performed.

• 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
• MDR Report Key: 11026966
• MDR Text Key: 222018528
• Report Number: 2017233-2020-01537
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEMODIALYSIS RELIABLE OUTFLOW (HERO®) GRAFT; HEMODIALYSIS RELIABLE OUTFLOW (HERO®) GRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR