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

Catalog Number HT066080A

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/24/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a patient underwent a right axillopopliteal bypass for a final attempt to salvage the lower limb utilizing two gore® propaten® vascular grafts.It was reported the two 6 mm by 80 cm grafts were sewn together and implanted.Reportedly, the patient was doing fine postoperatively.Post op ct scan following the original surgery looked favorable.Three months postop, on an unknown date, the patient was picking up a backpack and felt a "pop".A reintervention procedure was performed.Reportedly, all the anastomoses were still intact, but one of the grafts, approximately 2 cm distal to the graft-to-graft anastomosis was circumferentially torn.It is unknown which of the two grafts ruptured.The graft was ligated to stop the bleeding, and a viabahn device was implanted.The patient will eventually have an amputation procedure.

Manufacturer Narrative

As two devices were implanted during this procedure, and its unknown which device contributed to the adverse event, the following device is also included within this report: serial number - (b)(6), unique identifier (udi) # - (b)(4), catalog number - ht066080a.A review of the manufacturing records for both devices indicated the lots met all pre-release specifications.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® 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: 17589433
• MDR Text Key: 321592898
• Report Number: 2017233-2023-04218
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132606641
• UDI-Public: 00733132606641
• 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
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HT066080A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Date Device Manufactured: 11/17/2022
• 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): Other