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

Catalog Number HAX01A

Device Problem Insufficient Information (3190)

Patient Problem Swelling (2091)

Event Date 04/01/2017

Event Type  Injury  

Manufacturer Narrative

No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed at this time.The device remains implanted.Therefore, direct product analysis was not possible.

Event Description

On an unknown date, a gore® propaten® vascular graft, was implanted in a axillobifemoral procedure.On an unknown date during the patient's follow-up visit, a perigraft fluid accumulation was observed.Intervention was performed and the graft remains implanted.

Manufacturer Narrative

Date of event was estimated, based on information from complainant.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6595826
• MDR Text Key: 76126097
• Report Number: 2017233-2017-00276
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

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
• Device Catalogue Number: HAX01A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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