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

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Hematoma (1884)

Event Date 12/28/2021

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.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 literature article was reviewed: alexopoulou-prounia, l.Et al.(2021) ¿a unique case of an expanded polytetrafluoroethylene graft rupture 14 years after abdominal aortic aneurysm open repair managed with placement of a thoracic endograft,¿ aorta, 09(06), pp.224¿227.A unique case of an expanded polytetrafluoroethylene graft rupture 14 years after abdominal aortic aneurysm open repair managed with placement of a thoracic endograft (readcube.Com).Doi: 10.1055/s-0041-1736652.This article is a case presentation of a 71-year-old male who experienced an expanded polytetrafluoroethylene (eptfe) tube graft rupture that occurred 14 years after abdominal aortic aneurysm (aaa) repair.Authors describe a unique case of an eptfe graft rupture, fourteen years after aaa repair that was successfully managed with endovascular repair and iliolumbar embolization.On preoperative computed tomography angiography (cta) for the original procedure, the aaa had a 1 cm in length reverse taper infrarenal neck, justifying open repair.The patient¿s original elective repair was accomplished with an 18-mm tube eptfe graft (gore-tex stretch vascular graft) without complications.Fourteen years after the original repair, the diagnosis of the graft rupture was made on cta with three-dimensional reconstruction, determining the exact level of the graft disruption.Adjacent to the graft, a large retroperitoneal hematoma was identified.The patient then underwent a minimally invasive endovascular procedure to address the issue (instead of an open surgery).Therefore, no histologic evaluation could be performed to assess the internal structure of the prosthetic material, as well as the mechanism of the rupture.Graft dilatation of eptfe tube grafts can be anticipated up to 20% of their initial diameter, after a mean implantation time of 6 years.In our case, we did not notice any indication of chronic graft dilation contributing to graft rupture.Specific surgical maneuvers, such as application of clamps to the graft or the placement of the prosthesis under excessive tension may contribute to its failure.In our case, surgical maneuvers were unlikely to have contributed to the graft rupture, since the location of the rupture was distant from all maneuvers and the clamping area, close to the anastomosis.Alternatively, a calcified plaque of the aaa sac that is imbricated over the graft may lead to its erosion.In our case, calcification of the aaa sac was not identified.Patient¿s recent repair included use of a gore tag conformable thoracic stent graft that was advanced and deployed without issue and demonstrated no endoleak.Postoperatively, the patient was hemodynamically stable and received thromboprophylaxis with 40-mg enoxaparin twice a day.On the third postoperative day, the patient postoperatively, an increase in the size of the existing hematoma with active extravasation occurred and was managed with iliolumbar artery embolization and blood transfusion of a total of (b)(4) units of packed red blood cells.Authors attributed the postoperative bleeding to local tissue avulsion of the right iliolumbar artery branches related to the rapidly expanding retroperitoneal hematoma in conjunction with anticoagulation, although given at intermediate doses.The rest of the postoperative course was reported as uneventful.The patient remains in good condition and ctas on the follow-up at 37th day and 10 months revealed no endoleak.2200-a other used to capture hematoma with reintervention.

• 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 ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19039527
• MDR Text Key: 339320696
• Report Number: 2017233-2024-04793
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/04/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 71 YR
• Patient Sex: Male