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

Catalog Number HAX01J

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2023, this patient underwent an axillobifemoral bypass (or, axillobipopliteal bypass) using a gore® propaten® vascular graft (propaten graft) to repair the iliac artery occlusion.Reportedly, during the procedure, three support rings were removed from the propaten graft.The rings were properly removed one by one and the reinforcing membrane was not injured.On (b)(6) 2023, the patient alleged swelling near the left femoral artery (or popliteal artery) anastomosis.Ct showed that the propaten graft was detached from the anastomosis, so a surgery repair was performed.During the reoperation, it was confirmed that the propaten graft was detached (separated) from the patient vessel at the anastomosis area and that the propaten graft near the anastomosis was partially torn (graft material tear).The propaten graft near the torn area was removed and partially replaced with a non-gore graft (triplex 8 mm), and reanastomosis with the patient vessel was performed.No transfusion was performed.The patient tolerated the procedure.The physician reportedly stated as follows: it may be that the propaten graft was pulled with exsessive force during the initial procedure, but the cause is unknown.The patient said he had no idea that he had done any strenuous exercise.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: code "other" was selected as the medical device was discarded at facility.Return not possible.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.

Manufacturer Narrative

H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d12: according to the gore® propaten® vascular graft instructions for use (ifu), 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.Evaluation summary: the case description could not be confirmed, as the provided images were not sufficient for evaluation.The reported failure modes reflect the case description but could not be confirmed.The evaluation 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: mami nagashima ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18155856
• MDR Text Key: 328353177
• Report Number: 2017233-2023-04411
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K901641
• 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,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAX01J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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