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

Catalog Number ECH060040

Device Problems Complete Blockage (1094); Peeled/Delaminated (1454)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/19/2023

Event Type  Injury  

Event Description

Within the article ¿potential prosthetic arterio-venous graft dissection: a rare case¿ accepted on january 19, 2023, to be appeared in the vascular specialist international, 38:7, the following was indicated: the patient is a 46-year-old afro-caribbean male with a history of hypertensive nephropathy, two failed renal transplants and self-cannulation of gore® acuseal vascular graft placed 8 months prior to explant.Approximately 6 months after implant the patient had an after duplex ultrasound [dus] that showed two areas of stenosis.A successful ir [interventional radiology] procedure under local anesthesia with a 6mm balloon dilation for two areas of stenosis in the upper arm at the site of his graft cannulation was performed (mpdcase: (b)(4).Three weeks later, he presented with similar complaints and duplex dus showed complete thrombosis of the graft.This successful ir procedure included mechanical thrombectomy and then dilation with a high pressure 6mm balloon (mpdcase: (b)(4).Then, two weeks later, he presented with poor flow and hyperkalemia.The dus showed complete occlusion.Due to the recent ir procedures, a surgical rescue was performed.The graft was found to be completely thrombosed from brachial artery to axillary vein.The appearance of graft was asymmetrical.Upon disconnecting the graft, dissection of the layers of the graft was noticed with clots within its layers.The graft was completely excised and was replaced with a new graft.The scans from this case were reviewed in multidisciplinary team meeting and there were two images on the dus [scan not specified] that showed loss of continuity of graft wall with some depression that was possibly missed by the sonologist due to the rarity of dissection.¿the major take-away from this case is to be aware of graft dissection as a rare complication of prosthetic grafts, particularly in cases of repeated graft thrombosis over a short period of time.Another learning point is the importance of appropriate training of patients for self-cannulation.Emphasis should be on not to exceed recommended needle size for the graft and use stepladder technique rather than buttonhole technique.¿ it was reported that the day after the new graft was placed the patient was able to be dialyzed.Further details regarding the gore® acuseal vascular graft place were not provided.

Manufacturer Narrative

Patient identifier: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Date of event was determined as date when literature article was accepted, here (b)(6), 2023.Implant date/explant date: the implant and explant dates were requested from the author, but not provided yet.Device evaluated by mfr: as the status of the device is unknown, no investigation of the devices can be performed.Device evaluated by mfr: review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.The patients age was 46 years and the gender male, as stated in the article.The author was contacted and further details requested, such as lot- / serial no., implant- and explant dates, patient data and possible root cause, but were not provided yet.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.

Manufacturer Narrative

The physician provided the lot- / serial no.And stated that he can show the notes and can go through the required details without compromising data protection and patient privacy to the responsible gore staff member.Unfortunately he can¿t email patient information and required a face to face meeting in the hospital.Multiple attempts were made to schedule a meeting, however no meeting has taken place yet.As the status of the device is unknown, no further investigation of the device can be performed.Neither clinical images enabling direct assessment of product performance, nor the device was returned for evaluation.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.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.

• 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: 16617298
• MDR Text Key: 312016008
• Report Number: 2017233-2023-03818
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2022
• Device Catalogue Number: ECH060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male