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

Catalog Number ECH060040W

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  Injury  

Event Description

It was reported to gore that on (b)(6) 2021, the patient was implanted with gore® acuseal vascular graft (avg) in the forearm for dialysis.The hemodialysis access was utilized to perform dialysis puncture three times a week after surgery.On the same day, the physician feedbacked graft delamination after the surgery.The avg access hadn't been used yet.The physician performed balloon dilation was on the layered area of avg.The patient tolerated the procedure and in good condition.

Manufacturer Narrative

H3: other - device was still implanted, therefore, it couldn't be returned for evaluation.H6: a review of the manufacturing records indicated the lots met all pre-release specifications.The case description could not be confirmed, as no device was returned.The reported failure mode reflects the case description but could not be confirmed.The identity of the device was provided; therefore, the device history record was examined.The evaluation found no anomalies attributable to the manufacture of the device.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.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19113241
• MDR Text Key: 340225360
• Report Number: 2017233-2024-04832
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2024

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/13/2023
• Device Catalogue Number: ECH060040W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/15/2024
• Date Device Manufactured: 04/13/2020
• 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