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

Catalog Number HT066070A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Seroma (2069)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

On (b)(6) 2023, a patient underwent femoral popliteal bypass surgery for peripheral arterial disease (pad) and claudication using a gore® propaten® vascular graft in the right leg.On (b)(6) 2023, the patient underwent thrombectomy for a thrombosed graft.Some seroma fluid was noted and cultured at this time.The culture was negative.On an unknown date, the patient returned with a red skin rash where the graft was implanted.It was treated with topical antibiotics and ciprofloxacin, which cleared it up.On (b)(6) 2024 the graft was explanted.Reportedly, the graft was patent, but there was a large seroma from the femoral to popliteal, and the patient was symptomatic.The entire graft was involved, no evidence of incorporation.A small piece of the explanted graft will be returned.

Manufacturer Narrative

A review of the manufacturing records indicated the lots met all pre-release specifications.Product return evaluation: one segment of a gore® propaten® vascular graft (thin wall removable rings) in 10% formalin.Was returned.The received segment of device featured a propaten® blue line pattern, an inner diameter of approximately 6 mm, a relaxed length of approximately 10 cm, and appeared to be a thin-walled configuration.Both ends of the segment had rings fully attached, but the center of the segment had both rings and film removed.This center section appeared to have a tear or cut that was stitched up with sutures; this tear did not extend the circumference of the graft.The abluminal and luminal surfaces of the graft were largely devoid of tissue.The luminal surface of the graft had dark red-brown staining and a viscous red-brown fluid could be seen inside some graft sections.The device was generally patent, but its condition can not be confirmed upon removal from the patient.The graft was examined for material disruptions with the aid of a stereomicroscope.Neither end of the graft appeared to be clean cut.No histopathological examination was performed.The examination found no anomalies attributable to the manufacture of the device.

• Brand Name: GORE® PROPATEN® 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: jorja nackard ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18623683
• MDR Text Key: 334331029
• Report Number: 2017233-2024-04584
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132606627
• UDI-Public: 00733132606627
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

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 Catalogue Number: HT066070A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 02/01/2024
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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: 53 YR