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

Catalog Number ECH060040

Device Problems Partial Blockage (1065); Peeled/Delaminated (1454); Dent in Material (2526); Device Stenosis (4066)

Event Date 03/22/2024

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following was reported to gore: on (b)(6) 2023, the patient underwent a procedure where a gore® acuseal vascular graft was implanted as an av graft between the brachial artery and the brachial vein with a total length of 15 cm.On (b)(6) 2024, it was reported that the first 5cm from the venous anastomosis and first 5cm from the arterial anastomosis were undamaged.However, the middle 5cm of the graft appeared dented and had a decreasing shunt flow.To increase the shunt flow, the physician performed a pta (thrombolysis).The damaged part of the acuseal graft was limited for cannulation due to the middle section of the graft being dented.Although the shunt flow is sufficient for dialysis and the graft is still punctured, the dent is still present in the middle 5 cm of the graft and the shunt flow is now decreasing further.Some time in early to mid (b)(6) 2024, the physician performed another pta.The pta did not provide desired results.On (b)(6) 2024, the acuseal graft was completely explanted and replaced with gore® propaten® vascular graft.The procedure was concluded without any other reported issue and patient tolerated the procedure.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.A2/a3 was added.H6: evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing records indicated the lots met all pre-release specifications.Explant evaluation summary: the graft fragment was returned to w.L.Gore & associates for investigation.Submitted unfixed was one fragment of a gore acuseal vascular graft.One extremity was transversely transected (presumptive arterial).The other extremity was obliquely transected (presumptive venous).Both extremities had fine, blue monofilament anastomotic sutures present.The abluminal surface was generally devoid of tissue with several scattered, slightly raised plaques of translucent to tan, smooth tissue.There were numerous semi-circular punctures along the length of the fragment.The lumen was filled by a brown, gelatinous coagulum.The specimen was partially compressed for the first 70 mm from the oblique extremity.The specimen was then bent at an angle, at approximately 45 degrees.The vascular graft fragment appeared to be occupied with biologic material from microct images provided.There was evidence of varying degrees of delamination throughout the graft fragment, correlating to areas of cannulation.A false lumen was also visible.The graft fragment was not properly stored in a fixative solution for proper preservation of the tissue on and within the device.Therefore, a histopathological examination of the tissue could not be performed due to the lack of proper fixation prior to arrival at w.L.Gore & associates.The graft fragment was transected into seven samples, and then subjected to an enzymatic digestion process to remove biologic debris.Following digestion all samples were examined for material disruptions with the aid of a stereomicroscope.Cannulation sites were present throughout the length of the graft fragment.Associated with some of these cannulation sites were multiple full-thickness back- and side-wall perforations, which were present along the length of the fragment.Layer separation between the outer eptfe and inner silicone layer was present along the length of the fragment and was associated with cannulation sites.At these areas of layer separation, tissue ingrowth was present.The material disruptions identified (i.E., cannulation marks, back- and side-wall perforations, transections, suturing, layer separation) were consistent with those caused by interaction with surgical instrumentation (i.E., dialysis needles, scalpel/scissors, suturing needle, cannulation), which were likely caused during surgical procedures.The exact time and cause of the outer eptfe and sinner silicone layer separation could not be determined.In the instruction for use for the gore® acuseal vascular graft the following is stated: warnings: when cannulating gore® acuseal vascular graft puncture sites must be adequately separated when repeated needle punctures of the graft are necessary.Multiple punctures in the same area may result in damage of the graft material that can lead to pain at the cannulation site, partial or complete occlusion, serious blood loss, pseudoaneurysm or additional interventions to resolve.Adverse events potential device and procedure-related adverse events complications which may occur in conjunction with the use of any vascular prosthesis and/or vascular or related procedures include but are not limited to: partial or complete occlusion due to hemodynamically significant stenosis or thrombosis; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; erosion of subcutaneous tissue over the vascular graft; perigraft hematomas; blood loss or hemorrhage from graft cannulation site, pseudoaneurysm, mechanical damage or tearing of the suture line, graft, and/or host vessel.

Event Description

The following was reported to gore: on (b)(6) 2023, the patient underwent a procedure where a gore® acuseal vascular graft was implanted as an av graft between the brachial artery and the brachial vein with a total length of 15 cm.A 15 gauge needle was used for dialysis using a rope ladder technique.On (b)(6) 2024, it was reported that the first 5 cm from the venous anastomosis and first 5cm from the arterial anastomosis were undamaged, whereas the middle 5 cm of the graft appeared dented and had a decreasing shunt flow.To increase the shunt flow, the physician performed a thrombolysis and a percutaneous transluminal angioplasty (pta).They reportedly no longer punctured the damaged central part of the graft, but only the limited undamaged sections to the left and right of the damaged section.Although the shunt flow is sufficient for dialysis and the graft is still punctured, the dent is still present in the middle 5 cm of the graft and the shunt flow is now decreasing further.Some time in early to mid (b)(6) 2024, the physician performed another pta.The pta did not provide desired results.On (b)(6) 2024, the acuseal graft was completely explanted and replaced with gore® propaten® vascular graft.The procedure was concluded without any other reported issue and patient tolerated the procedure.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• 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: vanessa rodriguez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19140576
• MDR Text Key: 340560132
• Report Number: 2017233-2024-04844
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECH060040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/31/2024; 07/17/2024
• Supplement Dates FDA Received: 06/26/2024; 07/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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
• Patient Age: 50 YR
• Patient Sex: Female