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

Model Number V06070L

Device Problems Complete Blockage (1094); Device Stenosis (4066)

Patient Problems Thrombosis/Thrombus (4440); Peripheral Edema (4578)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

The device remains implanted in the patient.Therefore a device evaluation could be performed.A review of the manufacturing records indicated the lots met all pre-release specifications.The site study database was reviewed.The provided information is captured in the event description.The available information reported to gore does not reasonably suggest a potential malfunction has occurred.The information indicated suspected cause for device occlusion was disease-related (peripheral artery disease (pad)).The instruction for use states the following: possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis;.

Event Description

On (b)(6) 2016, the patient presented with peripheral artery disease (pad) and was treated for occlusion of the left popliteal artery with a gore-tex® vascular graft.Distal and proximal anastomoses were below knee.Hematoma evacuation was performed after the procedure.On (b)(6) 2016, the patient presented with an edema on the left limb, oozing of the left popliteal scar, thrombosis inside the graft at the distal anastomosis, and thrombosis of the tibial arteries.Therefore a reintervention was performed.Open repair thrombectomy was performed, however, patency of the graft could not be restored.Therefore a new gore-tex® vascular graft was implanted to bypass the lesion.It was reported that the thromboses were pad related.On march 5, 2016, the patient was discharged home with no further events recorded.

Manufacturer Narrative

Cause investigation and conclusion a review of the manufacturing records indicated the lots met all pre-release specifications.The device remains implanted and was therefore not available for engineering evaluation.The available information reported to gore does not reasonably suggest a potential malfunction has occurred.The information indicated suspected cause for device occlusion was disease-related (peripheral artery disease (pad).The reported thrombosis represents a known complication or adverse event that can occur.In the instructions for use the following is stated: possible complications with the use of any vascular prosthesis.Complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis.Based on the event description and the subsequent investigation the root cause of the thrombosis could not be established.However, the reported information indicates that the thrombosis is related to peripheral artery disease.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15498424
• MDR Text Key: 300703976
• Report Number: 2017233-2022-03358
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132614042
• UDI-Public: 00733132614042
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2019
• Device Model Number: V06070L
• Device Catalogue Number: V06070L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male