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

Device Problem Complete Blockage (1094)

Patient Problem Thrombus (2101)

Event Date 06/17/2015

Event Type  Injury  

Manufacturer Narrative

Literature citation: krol, emilia, brandt, colin t., blakeslee-carter, juliet, ahanchi, sadie s., dexter, david j., karakla, daniel, and panneton, jean m.2019 vascular interventions in head and neck cancer patients as a marker of poor survival.Journal of vascular surgery 69:181-189 this report addresses potential, but unconfirmed, instances of loss of patency with the propaten vascular graft.The viabahn patency data is being reported separately.

Event Description

The following information was reported to gore: in an abstract titled "vascular interventions in head and neck cancer patients as a marker of poor survival", it states a retrospective review of cancer patients treated by head and neck surgery and vascular surgery between 2007 and 2015 was conducted.Twenty-two patients had stents placed during index procedures.Gore® viabahn® endoprostheses were utilized in eight patients.Additionally, eight bypass procedures were performed, seven had vein grafts.One bypass patient had a gore® propaten® vascular graft, for recurrent carotid stenosis from radiation arteritis.The primary patency rates for both bypass and stents were analyzed.The mean patency rate for patency with bypass was 16.6 months (range, 1 day to 23 months) compared with 29.8 months (range 3 days to 55 months) for patients treated with stents.Primary patency at 1 year was 71% and 66% for bypass and stent patients respectively.There was no difference between the primary patency for the two groups (p=.604).

Manufacturer Narrative

H.6.Conclusion code 1: updated.

Manufacturer Narrative

Ref: mfr.Report # 2017233-2019-00870 for viabahn event.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9078802
• MDR Text Key: 162942633
• Report Number: 2017233-2019-00871
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR