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

Catalog Number ECH060040

Device Problem Peeled/Delaminated (1454)

Patient Problem Obstruction/Occlusion (2422)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: as the device remains implanted, no investigation of the device can be performed.A product history record review is being conducted.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 the patient underwent surgical treatment for an occluded gore® acuseal vascular graft shunt which was implanted on (b)(6) 2022.It was stated that during the revision on (b)(6) 2023, the physician opened the shunt and looked directly at the exposed polymer layer on the opposite side, which lay free in the vessel.In the angiography image, what appear to be air bubbles, are detachments from the polymer layer.In the sonography, it could be seen very well, that small parts of the layer protruded in the lumen.Under the polymer layer hematomas were present, which had lifted the layer as punctual.The device had to be abandoned and a new gore® acuseal vascular graft shunt had to be created on (b)(6) 2023.The physician stated that this could have been occurred during puncture of the graft and that perhaps blood was pumped into the graft wall.The patient could remember such an incorrect puncture.

Manufacturer Narrative

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.The device remains implanted and was, therefore, not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.The physician stated that this could have been occurred during puncture of the graft and that perhaps blood was pumped into the graft wall.The patient could remember such an incorrect puncture.With the information provided to gore, the cause of the reported event cannot be established.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: 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.

• 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: 16805535
• MDR Text Key: 313911595
• Report Number: 2017233-2023-03885
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/23/2023
• Device Catalogue Number: ECH060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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: 59 YR
• Patient Sex: Male