MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® VIABAHN® ENDOPROSTHESIS

Catalog Number PAC051002

Device Problem Complete Blockage (1094)

Patient Problem Not Applicable (3189)

Event Date 05/27/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

In a literature article titled "ten-year experience with management of aortoiliac aneurysms using retrograde endovascular internal iliac artery preservation" it states gore® viabahn® endoprostheses were utilized in conjunction with apollo aortouniiliac devices on the contralateral side, positioned from the external iliac artery into the internal iliac artery as a bridging stent and femorofemoral bypass.Type ib endoleak associated with the viabahn was diagnosed in 1 patient.Subsequent evaluation revealed that the viabahn was undersized for external iliac artery and another procedure was performed to implant a larger viabahn distally.A viabahn occlusion was diagnosed in 1 patient, at one month.This patient had a 4-mm iia and a 5-mm viabahn implanted.This patient did not exhibit symptoms of pelvic ischemia.This event addresses the occlusion at 1 month.

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified the lot met all pre-release specifications.

Manufacturer Narrative

Conclusion: according to the gore® viabahn® endoprosthesis instructions for use, (ifu), device and procedure related complications include, but are not limited to occlusions.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6982498
• MDR Text Key: 90388861
• Report Number: 2017233-2017-00564
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2017

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: PAC051002
• Device Lot Number: 9179406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/20/2017; 12/12/2017; 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2011
• 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): Other
• Patient Age: 73 YR