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

Device Problems Contamination (1120); Peeled/Delaminated (1454); Material Puncture/Hole (1504); Material Rupture (1546); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Ischemia (1942); Rupture (2208); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/15/2022

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Date the events occurred remains unknown, so the date when the manuscript was received, here (b)(6) 2022, was chosen as the event date.Here as implant- and explant dates the observational cohort study in the period from january 2011 to december 2019 was chosen.As the status of the devices is unknown, no investigation of the devices can be performed.Review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.The author was contacted and further details requested, such as lot- / serial no.'s, implant- and explant dates, patient data and possible root causes.The age of the patients as well as the gender is not stated in the manuscript.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 unpublished manuscript was reviewed: ¿cannulation damages after early cannulation vascular access graft based on clinical, ultrasound and microscopical observations¿ created by marco franchin et al.From the university of insubria school of medicine, varese, italy.The papers aim is to analyze the effects of frequent cannulations on early cannulation arteriovenous graft (avg) created in one center.This is a single centre, prospective, observational cohort study in the period from january 2011 to december 2019.The intention is to assess the durability of the the gore® acuseal vascular graft, comparing clinical data and ultrasound images to microscopical morphological findings obtained on explanted grafts.For the present study all the damaged grafts explanted during the study period were considered.Indication to graft explant were extensive damages that make the hemodialysis cannulation difficult, or associated to pseudoaneurysms, haematoma and bleeding.In the clinical practice, other common indication to graft explant are severe graft infections (according to kingsmore et al.), outflow vein failure associated to recurrent thrombosis, high flow avg with hemodialysis access-induced distal ischemia or heart failure, patient¿s request after kidney transplant.During the period of study, 111 (33 %) grafts were explanted.Among them 33 (30 %) were explanted for graft lesion: extensive damage due to chronic cannulation (n=29), or large pseudoaneurysm and graft rupture due to wrong cannulation (n=4).Other common leading causes of graft explantation were as follow: outflow failure (n=43), infections (n=18), kidney transplant (n=10), high flow graft (n=7).Further details regarding the gore® acuseal vascular graft were not provided.

Manufacturer Narrative

H6 evaluation codes investigation findings c20 was selected because no device investigations were able to be performed as no further information was able to be obtained from the authors (despite multiple attempts) and we did not receive the devices back for evaluation.Multiple attempts were made to obtain additional information from the author, like event dates, serial no.'s, implant dates, images in dicom format, possible root causes and patient data and/or if he can you confirm that our gore devices have not malfunctioned and the complications and/or adverse events observed are not attributable to our gore® acuseal vascular grafts.The requests remained unanswered.The serial numbers remain unknown, therefore a review of the manufacturing records could not be performed.Neither images enabling direct assessment of product performance nor the product itself were returned for evaluation.With no additional information provided, gore is unable to perform further investigations of this complaint and the cause of the reported events could not be established.

• 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: 16119898
• MDR Text Key: 306880932
• Report Number: 2017233-2023-03626
• 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,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• 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