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

Catalog Number RRT06060080L

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

H6 - code c19: a review of the manufacturing and packaging records indicated the lots met all pre-release specifications.H6 (h3) - code b20: device remains implanted; therefore, direct product analysis was not possible.H6 - code b15: images were provided; results pending completion of investigation.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

The following was reported to gore: on (b)(6) 2019, a gore-tex® vascular graft (thin-walled, removable rings) was implanted in a bypass procedure, from the axillary artery to the proximal superficial femoral artery (sfa).During a follow-up on (b)(6) 2023, the imaging scan showed the vascular graft appearance was normal.As reported, the physician was not aware of any trauma the patient experienced.The physician did speculate it was possible the iliac crest was rubbing on the vascular graft, leading to some deterioration.It was also possible the patient changed sleeping positions which caused the vascular graft to degrade.During a follow-up on march 13, 2024, imaging showed the 6mm gore-tex® vascular graft appeared to be disrupted in the distal to mid-section.As reported, the patient was asymptomatic.Re-intervention was planned for a later date.On (b)(6) 2024, the re-intervention was performed.An 8x25 gore® viabahn® endoprosthesis was implanted to cover the disrupted section of the gore-tex® vascular graft.Patient was recovering well following the successful procedure.

Manufacturer Narrative

H6 - code b13: the device was not returned to w.L.Gore & associates for investigation.Submitted in this case were ultrasound images of an implanted gore tex® vascular graft (thin wall removable rings).The provided images were insufficient for an engineering evaluation.The identity of the device was provided; therefore, the device history record could be consulted.The case description could not be confirmed, as images could not be evaluated.The evaluation found no anomalies attributable to the manufacture of the device.

Event Description

The following was reported to gore: on (b)(6) 2019, a gore-tex® vascular graft graft (thin-walled, removable rings) was implanted in a bypass procedure, from the axillary artery to the proximal superficial femoral artery (sfa).During a follow-up on (b)(6) 2023, the imaging scan showed the vascular graft appearance was normal.As reported, the physician was not aware of any trauma the patient experienced.The physician did speculate it was possible the iliac crest was rubbing on the vascular graft, leading to some deterioration.It was also possible the patient changed sleeping positions which caused the vascular graft to degrade.During a follow-up on (b)(6) 2024, imaging showed the 6mm gore-tex® vascular graft appeared to be disrupted in the distal to mid-section.As reported, the patient was asymptomatic.Re-intervention was planned for a later date.On (b)(6) 2024, the re-intervention was performed.An 8x25 gore® viabahn® endoprosthesis was implanted to cover the disrupted section of the gore-tex® vascular graft.Patient was recovering well following the successful procedure.

• Brand Name: GORE-TEX® 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19000310
• MDR Text Key: 338881605
• Report Number: 2017233-2024-04767
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132610945
• UDI-Public: 00733132610945
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K880167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2024
• Device Catalogue Number: RRT06060080L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2019
• 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: 78 YR
• Patient Sex: Male