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

Catalog Number ECH060040

Device Problems Peeled/Delaminated (1454); Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/11/2022

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Images were provided and an imaging evaluation conducted.The identity of the device is consistent with the device described in the case.The condition of the device is consistent with the case description but could not be confirmed due to the quality of the images provided.The reported failure mode is consistent with the condition of the device in the provided pictures.The examination found no anomalies attributable to the manufacture of the device.A product history record review will be performed as well as the device evaluation.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

It was reported to gore that a gore® acuseal vascular graft was explanted due to an occlusion of the graft.During explantation it was noticed that the graft appeared to be delaminated.The physician completed the surgery with a gore® propaten® vascular graft.

Manufacturer Narrative

D6a as for the implant date only year and month was provided, (b)(6) 2022 was chosen.H6 evaluation codes investigation findings c19 refers to the product history review: a review of the manufacturing- and heparin coating records indicated the lots met all pre-release specifications.Explant evaluation summary: a device fragment was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore® acuseal vascular graft device fragment (vgf) that had been transected prior to arrival at w.L.Gore & associates.The abluminal surface was covered in a membrane of brown/tan tissue, which was eccentrically deposited with a thin layer along one surface and a moderately thick layer on the other.The lumen was patent and generally devoid of tissue, except for a thin layer of white/tan tissue.Near extremity a, a slight bulge on the abluminal aspect was present.On the luminal aspect of the bulge, there was a narrowing of the lumen.In the area of the bulge, layer explant report ¿ (b)(4) w.L.Gore & associates, inc.¿ confidential information 2 separation was present, starting at extremity a, between the outer eptfe and silicone layer.The layer separation was only present on half the circumference of the fragment (in the specified area) and the extent (length) of layer separation could not be determined without excessive manipulation.Red tissue was present in-between the outer eptfe and silicone layer in the area where the bulge was present.Multiple cannulation marks were present on the abluminal and luminal surface in the area of layer separation and bulge.Multiple cannulation marks were also present along the length of the greater curvature of the fragment.Histopathological examination of one transverse section of the graft was performed.The thick layer of abluminal connective tissue along one surface was associated with graft cannulation punctures, hemosiderin deposition, and mild chronic inflammation consistent with a resolving hematoma.There was a small quantity of proteinaceous coagulum on the inner surface of the outer graft wall consistent with some degree of silicone separation from the graft in the area of the cannulations.The degree of layer separation could not be determined, due to artifactual distortion that occurred due to histologic processing.There was no evidence of neointimal tissue that could contribute to luminal stenosis.Vgf was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the fragment was examined for material disruptions with the aid of a stereomicroscope and video borescope.Multiple luminal backwall scores and full thickness backwall perforations were present along the length of the fragment.The layer separation did not persist for the entire length of the fragment; however, the exact length of the layer separation could not be determined without excessive manipulation.The material disruptions identified (i.E., forceps disruption, cannulation marks, and transections) were consistent with those caused by surgical instruments (e.G., forceps, needle cannulation, scalpel/scissors), which were likely used during dialysis and/or a surgical procedure.The exact time and cause of the layer separation could not be determined with the information provided.Further information was requested from the physician, such as during what step or action the delamination happened, if the problem (delamination) happened after puncture of the implanted gore® acuseal vascular graft and what does the physician think is the cause of the delamination.It was stated that they found the delamination during explantation, that probably the delamination occurred because of the venipuncture and the physician thinks that the delamination could be caused by cannulation.In the instruction for use for the gore® acuseal vascular graft the following is stated: possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis; mechanical disruption or tearing of the suture line, graft, and / or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16119855
• MDR Text Key: 306880748
• Report Number: 2017233-2023-03625
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECH060040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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): Required Intervention