MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number 20059769

Device Problem Material Deformation (2976)

Patient Problem Pseudoaneurysm (2605)

Event Date 04/01/2012

Event Type  Injury  

Manufacturer Narrative

Event information such as item/lot number, implant date, date of explant, patient medical history was requested, however no information has been received.Due to an unknown lot/serial number and no device return, an investigation could not be performed.

Event Description

The following publication was reviewed; title: nonanastomotic pseudoaneurysm with complete disruption of an expanded polytetrafluoroethylene axillofemoral bypass graft.Source: annals of vascular surgery volume 26, issue 3, april 2012, pages 422.E9-422.E12.Article states: rupture of an expanded polytetrafluoroethylene (eptfe) vascular graft is rare.We report a non-anastomotic pseudoaneurysm associated with complete disruption of an eptfe graft that occurred 6 years after an axillofemoral bypass.The (b)(6)-year-old patient had undergone neither trauma nor infection.The aneurysmal segment was resected, and a new eptfe graft was interposed.The patient recovered uneventfully and was well 4 years later.Histologic analysis revealed a torn graft edge, consistent with a rupture due to excessive force, but scanning electron microscopy showed that the internal structure of the prosthesis was intact.The cause of the midgraft rupture remains unknown.

Manufacturer Narrative

The following publication was reviewed; title: non anastomotic pseudoaneurysm with complete disruption of an expanded polytetrafluoroethylene axillofemoral bypass graft.Source: annals of vascular surgery volume 26, issue 3, april 2012, pages 422.E9-422.E12.Article states: rupture of an expanded polytetrafluoroethylene (eptfe) vascular graft is rare.We report a non-anastomotic pseudoaneurysm associated with complete disruption of an eptfe graft that occurred 6 years after an axillofemoral bypass.The 81-year-old patient had undergone neither trauma nor infection.The aneurysmal segment was resected, and a new eptfe graft was interposed.The patient recovered uneventfully and was well 4 years later.Histologic analysis revealed a torn graft edge, consistent with a rupture due to excessive force, but scanning electron microscopy showed that the internal structure of the prosthesis was intact.The cause of the midgraft rupture remains unknown.

• Brand Name: GORE-TEX VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12010904
• MDR Text Key: 256720125
• Report Number: 2017233-2021-02083
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20059769
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 81 YR