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

Catalog Number HT066080A

Device Problem Occlusion Within Device (1423)

Patient Problems Embolism (1829); Occlusion (1984); Claudication (2550)

Event Date 04/20/2014

Event Type  Injury  

Event Description

In (b)(6) 2014, the patient presented with claudication.Bilateral external iliac artery and superficial femoral artery occlusions were identified.On (b)(6) 2014, two gore viabahn endoprostheses were implanted.On (b)(6) 2014, angiogram revealed filling defects and embolization with an occlusion of the viabahn device.The physician suspected the embolization was due to a previous myocardial infarction.(b)(6) 2014, axillobifemoral gore-tex stretch vascular graft was implanted to bypass the occluded iliac vessels including the right external iliac artery where the viabahn devices were implanted.Distal anastomosis of the axillobifemoral stretch vascular graft was at the profunda artery bilaterally.A right above the knee femoral-popliteal bypass graft was also implanted using a gore propaten vascular graft.The axillobifemoral gore-tex stretch graft occluded on (b)(6) 2014.A thrombectomy was performed to treat the vascular graft occlusion.The propaten graft was explanted and replaced with a removable ring gore-tex vascular graft.No report of an graft occlusion involving the propaten vascular graft was received.

Manufacturer Narrative

Evaluation in progress pending the completion of the manufacturing paperwork review.This event involved four gore devices: viabahn endoprosthesis - lot #12045257, mfr report #2017233-2014-00257; viabahn endoprosthesis - lot #12091352, mfr report #2017233-2014-00258; gore-tex stretch vascular graft - lot #11687160, mfr report #3006215353-2014-00001; gore propaten vascular graft - lot #4259301pp001, mfr report #2017233-2014-00259.

Manufacturer Narrative

Review of the manufacturing paperwork has been conducted.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3819414
• MDR Text Key: 4496917
• Report Number: 2017233-2014-00259
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• 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: 05/22/2014

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 Expiration Date: 09/30/2017
• Device Catalogue Number: HT066080A
• Device Lot Number: 4259301PP001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2013
• 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
• Patient Age: 61 YR